Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3)

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

Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

813

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
      • Buenos Aires, Argentina, C1250AAN
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1179AAB
        • Novo Nordisk Investigational Site
      • Lanus Este, Argentina, B1824KAJ
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7600GWV
        • Novo Nordisk Investigational Site
  • Croatia
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Slavonski Brod, Croatia, 35 000
        • Novo Nordisk Investigational Site
      • Virovitica, Croatia, 33000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00260
        • Novo Nordisk Investigational Site
      • Helsinki, Finland, FI-00100
        • Novo Nordisk Investigational Site
      • Kerava, Finland, FI-04200
        • Novo Nordisk Investigational Site
      • Oulu, Finland, 90220
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
  • France
      • Chalons-en-Champagne Cedex, France, 51005
        • Novo Nordisk Investigational Site
      • Corbeil Essonnes, France, 91106
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, France, 17019
        • Novo Nordisk Investigational Site
      • Le Creusot, France, 71200
        • Novo Nordisk Investigational Site
      • Nanterre, France, 92014
        • Novo Nordisk Investigational Site
      • Roubaix, France, 59100
        • Novo Nordisk Investigational Site
      • Strasbourg, France, 67000
        • Novo Nordisk Investigational Site
      • Venissieux, France, 69200
        • Novo Nordisk Investigational Site
  • Germany
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Duisburg, Germany, 47051
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Mannheim, Germany, 68163
        • Novo Nordisk Investigational Site
      • Oldenburg, Germany, 23758
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-12462
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-14233
        • Novo Nordisk Investigational Site
      • Athens, Greece, GR-17562
        • 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
  • Italy
      • Bologna, Italy, 40138
        • Novo Nordisk Investigational Site
      • Città di Castello, Italy, 06012
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20132
        • Novo Nordisk Investigational Site
      • Palermo, Italy, 90127
        • Novo Nordisk Investigational Site
      • Pavia, Italy, 27100
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Siena, Italy, 53100
        • Novo Nordisk Investigational Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 EC
        • Novo Nordisk Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Novo Nordisk Investigational Site
      • Delft, Netherlands, 2625 AD
        • Novo Nordisk Investigational Site
      • Hoofddorp, Netherlands, 2134 TM
        • Novo Nordisk Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3021 HC
        • Novo Nordisk Investigational Site
      • Rotterdam, Netherlands, 3039 BD
        • Novo Nordisk Investigational Site
      • Venlo, Netherlands, 5912 BL
        • Novo Nordisk Investigational Site
      • Zoetermeer, Netherlands, 2725 NA
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Novo Nordisk Investigational Site
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Belgrade, Serbia, 11080
        • Novo Nordisk Investigational Site
      • Kragujevac, Serbia, 34000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novo Nordisk Investigational Site
      • Genève 14, Switzerland, 1211
        • Novo Nordisk Investigational Site
      • Luzern 16, Switzerland, 6000
        • Novo Nordisk Investigational Site
      • St. Gallen, Switzerland, 9007
        • Novo Nordisk Investigational Site
      • Zollikerberg, Switzerland, 8125
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Ayr, United Kingdom, KA6 6DX
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Bradford-on-Avon, United Kingdom, BA15 1DQ
        • Novo Nordisk Investigational Site
      • Haxey, United Kingdom, DN9 2HY
        • Novo Nordisk Investigational Site
      • Headington, United Kingdom, OX3 7LE
        • Novo Nordisk Investigational Site
      • Rotherham, United Kingdom, S651DA
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Pell City, Alabama, United States, 35128
        • Novo Nordisk Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306-4652
        • Novo Nordisk Investigational Site
      • Mesa, Arizona, United States, 85213
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85027
        • Novo Nordisk Investigational Site
    • California
      • Burbank, California, United States, 91505
        • Novo Nordisk Investigational Site
      • Hawaiian Gardens, California, United States, 90716
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90017
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90022
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91324
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92108
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Colorado Springs, Colorado, United States, 80906
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Brandon, Florida, United States, 33511
        • Novo Nordisk Investigational Site
      • Coral Gables, Florida, United States, 33134
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33012
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33144
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33145
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33174
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Novo Nordisk Investigational Site
    • Indiana
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, United States, 46140
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • Novo Nordisk Investigational Site
    • New Jersey
      • Mine Hill, New Jersey, United States, 07803
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • North Massapequa, New York, United States, 11758-1802
        • Novo Nordisk Investigational Site
      • Syracuse, New York, United States, 13210
        • 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
      • Hickory, North Carolina, United States, 28601
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Novo Nordisk Investigational Site
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Delaware, Ohio, United States, 43015
        • Novo Nordisk Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330-3737
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97210
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446-1002
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Novo Nordisk Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Novo Nordisk Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Carrollton, Texas, United States, 75010
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75225
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76117
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77024
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77008
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77040
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77072
        • Novo Nordisk Investigational Site
      • Irving, Texas, United States, 75039
        • Novo Nordisk Investigational Site
      • Katy, Texas, United States, 77450
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78245
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • 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: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with 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 inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 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 (NYHA) class IV

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 1.0 mg
Drug: semaglutide
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Active Comparator: Exenatide ER 2.0 mg
Drug: exenatide
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Other Names:
  • Bydureon®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 56
Mean change in HbA1c from baseline to week 56.
Week 0, week 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Body Weight
Time Frame: Week 0, week 56
Mean change in body weight from baseline to week 56.
Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 56
Mean change in FPG from baseline to week 56.
Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
Time Frame: Week 0, week 56
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Week 0, week 56
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
Time Frame: Week 0, week 56
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures 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.
Week 0, week 56
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)
Time Frame: After 56 weeks' treatment
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
After 56 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)

December 2, 2013

Primary Completion (Actual)

July 13, 2015

Study Completion (Actual)

July 13, 2015

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

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

  • NN9535-3624
  • 2012-004826-92 (EudraCT Number)
  • U1111-1135-8647 (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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