Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes (SUSTAIN™ 4)

May 28, 2019 updated by: Novo Nordisk A/S

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1089

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

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1119ACN
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, C1056ABJ
        • Novo Nordisk Investigational Site
      • Godoy Cruz, Argentina, M5501ARP
        • Novo Nordisk Investigational Site
  • Croatia
      • Cakovec, Croatia, 40000
        • Novo Nordisk Investigational Site
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Krapinske Toplice, Croatia, 49217
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • France
      • Bobigny, France, 93009
        • Novo Nordisk Investigational Site
      • Bois-Guillaume, France, 76320
        • Novo Nordisk Investigational Site
      • Bourgoin-jallieu, France, 38302
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9, France, 85295
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • MARSEILLE Cédex 05, France, 13385
        • Novo Nordisk Investigational Site
      • MARSEILLE cedex 08, France, 13285
        • Novo Nordisk Investigational Site
      • NICE cedex 3, France, 06202
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Narbonne, France, 11108
        • Novo Nordisk Investigational Site
      • Paris, France, 75014
        • Novo Nordisk Investigational Site
      • Pierre-Bénite, France, 69495
        • Novo Nordisk Investigational Site
      • Pointe À Pitre, France, 97159
        • Novo Nordisk Investigational Site
      • Rang-du-fliers, France, 62180
        • Novo Nordisk Investigational Site
      • Saint Herblain, France, 44800
        • Novo Nordisk Investigational Site
      • Saint Nazaire, France, 44600
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67098
        • Novo Nordisk Investigational Site
      • Trinité - La Martinique, France, 97235
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 10409
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45276
        • Novo Nordisk Investigational Site
      • Jerichow, Germany, 39319
        • Novo Nordisk Investigational Site
      • Lampertheim, Germany, 68623
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Rostock, Germany, 18057
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70378
        • Novo Nordisk Investigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk Investigational Site
  • India
      • Kolkata, India, 700026
        • Novo Nordisk Investigational Site
      • New Delhi, India, 110001
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Novo Nordisk Investigational Site
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Novo Nordisk Investigational Site
      • Mysore, Karnataka, India, 570001
        • Novo Nordisk Investigational Site
      • Mysore, Karnataka, India, 570004
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400022
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400010
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600031
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700107
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44150
        • Novo Nordisk Investigational Site
    • México, D.F.
      • Distrito Federal, México, D.F., Mexico, 14080
        • Novo Nordisk Investigational Site
      • México D.F., México, D.F., Mexico, 11550
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novo Nordisk Investigational Site
      • Hoofddorp, Netherlands, 2134 TM
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3039 BD
        • Novo Nordisk Investigational Site
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • Novo Nordisk Investigational Site
      • Tetovo, North Macedonia, 1220
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 011234
        • Novo Nordisk Investigational Site
      • Iasi, Romania, 700469
        • Novo Nordisk Investigational Site
    • Arges
      • Pitesti, Arges, Romania, 110084
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400006
        • Novo Nordisk Investigational Site
  • Slovakia
      • Kosice, Slovakia, 04011
        • Novo Nordisk Investigational Site
      • Moldava nad Bodvou, Slovakia, 045 01
        • Novo Nordisk Investigational Site
      • Piestany, Slovakia, 92101
        • Novo Nordisk Investigational Site
      • Puchov, Slovakia, 02001
        • Novo Nordisk Investigational Site
      • Trencin, Slovakia, 91101
        • Novo Nordisk Investigational Site
  • Slovenia
      • Koper, Slovenia, SI-6000
        • Novo Nordisk Investigational Site
      • Ljubljana, Slovenia, 1525
        • Novo Nordisk Investigational Site
      • Novo mesto, Slovenia, 8000
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2001
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0183
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7450
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9GT
        • Novo Nordisk Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Novo Nordisk Investigational Site
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Novo Nordisk Investigational Site
      • Haxey, United Kingdom, DN9 2HY
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2RW
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Northwood, United Kingdom, HA6 2RN
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL6 8BQ
        • Novo Nordisk Investigational Site
      • Salford, United Kingdom, M6 8HD
        • Novo Nordisk Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk Investigational Site
      • Soham, United Kingdom, CB7 5JD
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA2 8PP
        • Novo Nordisk Investigational Site
      • Taunton, United Kingdom, TA1 5DA
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Ozark, Alabama, United States, 36360
        • Novo Nordisk Investigational Site
      • Tuscumbia, Alabama, United States, 35674
        • Novo Nordisk Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85295
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85018
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Carmichael, California, United States, 95608
        • Novo Nordisk Investigational Site
      • Chula Vista, California, United States, 91911
        • Novo Nordisk Investigational Site
      • Elk Grove, California, United States, 95758
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Oceanside, California, United States, 92056
        • Novo Nordisk Investigational Site
      • Orange, California, United States, 92868-2863
        • Novo Nordisk Investigational Site
      • Pomona, California, United States, 91767-3008
        • Novo Nordisk Investigational Site
      • Rialto, California, United States, 92376
        • Novo Nordisk Investigational Site
      • Rolling Hills Estates, California, United States, 90274
        • Novo Nordisk Investigational Site
      • Roseville, California, United States, 95661
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • San Mateo, California, United States, 94401
        • Novo Nordisk Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Novo Nordisk Investigational Site
      • Spring Valley, California, United States, 91978
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80239-3133
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33761
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33012
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Novo Nordisk Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
      • Lakeland, Florida, United States, 33805
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Novo Nordisk Investigational Site
      • Spring Hill, Florida, United States, 34609
        • Novo Nordisk Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Novo Nordisk Investigational Site
      • Winter Park, Florida, United States, 32789
        • Novo Nordisk Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30013
        • Novo Nordisk Investigational Site
      • Johns Creek, Georgia, United States, 30097
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30060
        • Novo Nordisk Investigational Site
      • Norcross, Georgia, United States, 30092
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • 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
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Novo Nordisk Investigational Site
    • Kansas
      • Park City, Kansas, United States, 67219
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Novo Nordisk Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Novo Nordisk Investigational Site
      • Natchitoches, Louisiana, United States, 71457-5881
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71107
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
      • Flint, Michigan, United States, 48504
        • Novo Nordisk Investigational Site
      • Sterling Heights, Michigan, United States, 48310-3503
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89119
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89120
        • Novo Nordisk Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novo Nordisk Investigational Site
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
      • Trenton, New Jersey, United States, 08611
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Novo Nordisk Investigational Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Novo Nordisk Investigational Site
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
      • Morganton, North Carolina, United States, 28655
        • Novo Nordisk Investigational Site
      • Shelby, North Carolina, United States, 28150
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Novo Nordisk Investigational Site
    • Ohio
      • Canal Fulton, Ohio, United States, 44614
        • Novo Nordisk Investigational Site
      • Carlisle, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
      • Maumee, Ohio, United States, 43537
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43623
        • Novo Nordisk Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Clairton, Pennsylvania, United States, 15025-3730
        • Novo Nordisk Investigational Site
      • Jersey Shore, Pennsylvania, United States, 17740
        • Novo Nordisk Investigational Site
      • Lansdale, Pennsylvania, United States, 19446-1002
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Novo Nordisk Investigational Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Novo Nordisk Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Knoxville, Tennessee, United States, 37912
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78756
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75251
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76117
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77074
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77058
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77040
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77055
        • Novo Nordisk Investigational Site
      • Humble, Texas, United States, 77338
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75061-2210
        • Novo Nordisk Investigational Site
      • Longview, Texas, United States, 75605
        • Novo Nordisk Investigational Site
      • Marshall, Texas, United States, 75670
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75075
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78209
        • Novo Nordisk Investigational Site
    • Utah
      • Saint George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Novo Nordisk Investigational Site
      • Winchester, Virginia, United States, 22601
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Wenatchee, Washington, United States, 98801-2028
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • 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, 18 years or older at the time of signing informed consent
  • Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
  • Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
  • Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value greater than or equal to 50 ng/L
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
  • Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
  • Acute coronary or cerebrovascular event within 90 days before randomisation
  • Heart failure, New York Heart Association Class IV
  • Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

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
Active Comparator: Insulin glargine
Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Experimental: Semaglutide 0.5 mg/week
Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Experimental: Semaglutide 1.0 mg/week
Drug: semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline
Time Frame: Week 0, week 30
Change in HbA1c from baseline to week 30.
Week 0, week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight From Baseline
Time Frame: Week 0, week 30
Change in body weight from baseline to week 30.
Week 0, week 30
Change in Fasting Plasma Glucose From Baseline
Time Frame: Week 0, week 30
Change in fasting plasma glucose from baseline to week 30.
Week 0, week 30
Change in Diastolic Blood Pressure.
Time Frame: Week 0, week 30
Change in diastolic blood pressure from baseline to week 30.
Week 0, week 30
Change in Systolic Blood Pressure.
Time Frame: Week 0, week 30
Change in systolic blood pressure from baseline to week 30.
Week 0, week 30
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
Time Frame: Week 0, week 30
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.
Week 0, week 30
Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)
Time Frame: Week 0, week 30
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.
Week 0, week 30
Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)
Time Frame: After 30 weeks treatment
Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment
After 30 weeks treatment

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)

August 4, 2014

Primary Completion (Actual)

September 3, 2015

Study Completion (Actual)

September 3, 2015

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-3625
  • 2013-004392-12 (EudraCT Number)
  • U1111-1146-0211 (Other Identifier: WHO)
  • NL47781.018.14 (Registry Identifier: National Registry in The Netherlands)

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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