Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes. (SUSTAIN 7)

October 2, 2019 updated by: Novo Nordisk A/S

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Novo Nordisk Investigational Site
      • Burgas, Bulgaria, 8000
        • Novo Nordisk Investigational Site
      • Montana, Bulgaria, 3400
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1233
        • Novo Nordisk Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Novo Nordisk Investigational Site
  • Croatia
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Krapinske Toplice, Croatia, 49217
        • Novo Nordisk Investigational Site
      • Rijeka, Croatia, 51 000
        • Novo Nordisk Investigational Site
      • Varazdin, Croatia, 42 000
        • Novo Nordisk Investigational Site
      • Virovitica, Croatia, 33000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Finland
      • Jyväskylä, Finland, 40100
        • Novo Nordisk Investigational Site
      • Kerava, Finland, FI-04200
        • Novo Nordisk Investigational Site
      • Kuusamo, Finland, 93600
        • Novo Nordisk Investigational Site
      • Raisio, Finland, 21200
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33210
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
  • Germany
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-17562
        • Novo Nordisk Investigational Site
      • Athens, Greece, 115 25
        • Novo Nordisk Investigational Site
      • Chalkida, Evia, Greece, GR-34100
        • Novo Nordisk Investigational Site
      • Ioannina, Greece, 45500
        • Novo Nordisk Investigational Site
      • Piraeus, Greece, GR-18536
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-54636
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57010
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR-57001
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • India
      • Hyderabad, India, 500 012
        • Novo Nordisk Investigational Site
      • Ludhiana, India, 141001
        • Novo Nordisk Investigational Site
      • New Delhi, India, 110001
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500004
        • Novo Nordisk Investigational Site
      • Visakhapatnam, Andhra Pradesh, India, 530002
        • Novo Nordisk Investigational Site
    • Assam
      • Guwahati, Assam, India, 781008
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, 560054
        • Novo Nordisk Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novo Nordisk Investigational Site
      • Kozhikode, Kerala, India, 673017
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452008
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Goa, Maharashtra, India, 403 202
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400022
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411004
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • New Delhi
      • Delhi, New Delhi, India, 110002
        • Novo Nordisk Investigational Site
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751005
        • Novo Nordisk Investigational Site
    • Punjab
      • Mohali, Punjab, India, 160062
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700017
        • Novo Nordisk Investigational Site
  • Ireland
      • Dublin, Ireland, DUBLIN 15
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 4
        • Novo Nordisk Investigational Site
      • Dublin, Ireland, DUBLIN 7
        • Novo Nordisk Investigational Site
      • Galway, Ireland, H91 YR71
        • Novo Nordisk Investigational Site
      • Gorey, Ireland
        • Novo Nordisk Investigational Site
  • Latvia
      • Riga, Latvia, LV-1002
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1024
        • Novo Nordisk Investigational Site
      • Riga, Latvia, LV-1038
        • Novo Nordisk Investigational Site
  • Lithuania
      • Kaunas, Lithuania, 48259
        • Novo Nordisk Investigational Site
      • Kaunas, Lithuania, 50009
        • Novo Nordisk Investigational Site
      • Panevezys, Lithuania, 37355
        • Novo Nordisk Investigational Site
      • Vilnius, Lithuania, 04318
        • Novo Nordisk Investigational Site
      • Vilnius, Lithuania, 08661
        • Novo Nordisk Investigational Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Novo Nordisk Investigational Site
      • Aveiro, Portugal, 3814-501
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1250-230
        • Novo Nordisk Investigational Site
      • Tomar, Portugal, 2304-909
        • Novo Nordisk Investigational Site
      • Viana do Castelo, Portugal, 4901-858
        • Novo Nordisk Investigational Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Novo Nordisk Investigational Site
  • Romania
      • Brasov, Romania, 500101
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 010507
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 13682
        • Novo Nordisk Investigational Site
      • Buzau, Romania, 120203
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800578
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
    • Mures
      • Tirgu Mures, Mures, Romania, 540142
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 81108
        • Novo Nordisk Investigational Site
      • Levice, Slovakia, 93401
        • Novo Nordisk Investigational Site
      • Piestany, Slovakia, 92101
        • Novo Nordisk Investigational Site
      • Poprad, Slovakia, 05801
        • Novo Nordisk Investigational Site
      • Prievidza, Slovakia, 97101
        • Novo Nordisk Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Novo Nordisk Investigational Site
      • La Roca del Vallés, Spain, 08430
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28009
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07014
        • Novo Nordisk Investigational Site
      • Segovia, Spain, 40002
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41010
        • Novo Nordisk Investigational Site
      • Vic (Barcelona), Spain, 08500
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • Novo Nordisk Investigational Site
      • Northwood, United Kingdom, HA6 2RN
        • Novo Nordisk Investigational Site
      • Romford, United Kingdom, RM1 3PJ
        • Novo Nordisk Investigational Site
      • Soham, United Kingdom, CB7 5JD
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO30 3JB
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD25 7NL
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Tuscumbia, Alabama, United States, 35674
        • Novo Nordisk Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Buena Park, California, United States, 90620
        • Novo Nordisk Investigational Site
      • Carlsbad, California, United States, 92008
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Huntington Park, California, United States, 90255
        • Novo Nordisk Investigational Site
      • Lincoln, California, United States, 95648
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Riverside, California, United States, 92506
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92103
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Van Nuys, California, United States, 91405
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33761
        • Novo Nordisk Investigational Site
      • Coral Gables, Florida, United States, 33134
        • Novo Nordisk Investigational Site
      • Edgewater, Florida, United States, 32132
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32806
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Port Orange, Florida, United States, 32127
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33614
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33634
        • Novo Nordisk Investigational Site
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Novo Nordisk Investigational Site
      • Bainbridge, Georgia, United States, 39819
        • Novo Nordisk Investigational Site
      • Conyers, Georgia, United States, 30094-5965
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30060
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30067
        • Novo Nordisk Investigational Site
      • Suwanee, Georgia, United States, 30024
        • Novo Nordisk Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Novo Nordisk Investigational Site
    • Illinois
      • Addison, Illinois, United States, 60101
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Gillespie, Illinois, United States, 62033
        • Novo Nordisk Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61602
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Novo Nordisk Investigational Site
      • Park City, Kansas, United States, 67219
        • Novo Nordisk Investigational Site
    • Kentucky
      • Covington, Kentucky, United States, 41011
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
      • Owensboro, Kentucky, United States, 42303
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • Oxon Hill, Maryland, United States, 20745
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Novo Nordisk Investigational Site
    • Michigan
      • Rochester, Michigan, United States, 48307
        • Novo Nordisk Investigational Site
    • Mississippi
      • Port Gibson, Mississippi, United States, 39150
        • Novo Nordisk Investigational Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Novo Nordisk Investigational Site
    • New Jersey
      • Trenton, New Jersey, United States, 08611
        • Novo Nordisk Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Novo Nordisk Investigational Site
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
      • Wadsworth, Ohio, United States, 44281-9236
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Novo Nordisk Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States, 19522
        • Novo Nordisk Investigational Site
      • Harleysville, Pennsylvania, United States, 19438
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224-2215
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15236
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Moncks Corner, South Carolina, United States, 29461
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Novo Nordisk Investigational Site
    • Tennessee
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76015
        • Novo Nordisk Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77074
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77081
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77040
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77025
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77079
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77090
        • Novo Nordisk Investigational Site
      • Katy, Texas, United States, 77450
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78231
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Utah
      • Riverton, Utah, United States, 84065
        • Novo Nordisk Investigational Site
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Washington
      • Spokane, Washington, United States, 99216-1557
        • Novo Nordisk Investigational Site
      • Walla Walla, Washington, United States, 99362-4445
        • Novo Nordisk Investigational Site
      • Wenatchee, Washington, United States, 98801-2028
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide 0.5 mg/Week
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
Experimental: Semaglutide 1.0 mg/Week
Drug: semaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
Active Comparator: Dulaglutide 0.75 mg/Week
Drug: Dulaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.
Active Comparator: Dulaglutide 1.5 mg/Week
Drug: Dulaglutide
Administered subcutaneously (s.c., under the skin) once-weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Week 0, week 40
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight (kg)
Time Frame: Week 0, week 40
Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Week 0, week 40
Change in Fasting Plasma Glucose
Time Frame: Week 0, week 40
Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Week 0, week 40
Change in Systolic and Diastolic Blood Pressure
Time Frame: Week 0, week 40
Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.
Week 0, week 40
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire
Time Frame: Week 0, week 40
The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication
Week 0, week 40
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Time Frame: After 40 weeks treatment
Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks treatment
Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile
Time Frame: Week 0, week 40
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40
Change From Baseline 7-point Self-measured Plasma Glucose Increment
Time Frame: Week 0, week 40
SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
Week 0, week 40
Change in Fasting Blood Lipids (Total Cholesterol)
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Fasting Blood Lipids (Triglycerides)
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Body Mass Index (BMI)
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40
Change in Waist Circumference
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40
Change in Short Form Health Survey (SF-36v2™)
Time Frame: Week 0, week 40
The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target
Time Frame: After 40 weeks of treatment
Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks of treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%
Time Frame: After 40 weeks treatment
Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%
Time Frame: After 40 weeks treatment
Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Time Frame: After 40 weeks of treatment
Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit
After 40 weeks of treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%
Time Frame: After 40 weeks of treatment
Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks of treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%
Time Frame: After 40 weeks treatment
Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks treatment
Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%
Time Frame: After 40 weeks treatment
Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
After 40 weeks treatment
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 40 weeks + follow-up of 5 weeks
A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).
40 weeks + follow-up of 5 weeks
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes
Time Frame: 40 weeks + follow-up of 5 weeks
A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
40 weeks + follow-up of 5 weeks
Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: 40 weeks + follow-up of 5 weeks
Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
40 weeks + follow-up of 5 weeks
Change in Amylase
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Lipase
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.
Week 0, week 40
Change in Pulse Rate
Time Frame: Week 0, week 40
Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2016

Primary Completion (Actual)

April 10, 2017

Study Completion (Actual)

May 19, 2017

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-4216
  • 2014-005375-91 (EudraCT Number)
  • U1111-1164-8495 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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