DiabetesPhase 3SUSTAIN™ 3NCT01885208

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

A Phase 3 study testing semaglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 146 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: semaglutide and exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 813 participants
Where: 146 sitesin 13 countries
Study dates: 2 Dec 2013to 13 Jul 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

146 sites in 13 countries.

Country

City, postcode or hospital

146 sites in 13 countries

United States76 sites

Novo Nordisk Investigational Site
Akron, Ohio, 44311
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Alexandria, Virginia, 22304
Novo Nordisk Investigational Site
Anniston, Alabama, 36207
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Brandon, Florida, 33511
Novo Nordisk Investigational Site
Burbank, California, 91505
Novo Nordisk Investigational Site
Carrollton, Texas, 75010
Novo Nordisk Investigational Site
Charleston, South Carolina, 29407
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chicago, Illinois, 60634
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45255
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80906
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80909
Novo Nordisk Investigational Site
Coral Gables, Florida, 33134
Novo Nordisk Investigational Site
Corvallis, Oregon, 97330-3737
Novo Nordisk Investigational Site
Dallas, Texas, 75225
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Delaware, Ohio, 43015
Novo Nordisk Investigational Site
Fort Worth, Texas, 76117
Novo Nordisk Investigational Site
Franklin, Indiana, 46131
Novo Nordisk Investigational Site
Glendale, Arizona, 85306-4652
Novo Nordisk Investigational Site
Greenfield, Indiana, 46140
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Hawaiian Gardens, California, 90716
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Hickory, North Carolina, 28601
Novo Nordisk Investigational Site
Houston, Texas, 77008
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77040
Novo Nordisk Investigational Site
Houston, Texas, 77072
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Irving, Texas, 75039
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49009
Novo Nordisk Investigational Site
Katy, Texas, 77450
Novo Nordisk Investigational Site
Lansdale, Pennsylvania, 19446-1002
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89103
Novo Nordisk Investigational Site
Lomita, California, 90717
Novo Nordisk Investigational Site
Los Angeles, California, 90017
Novo Nordisk Investigational Site
Los Angeles, California, 90022
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431
Novo Nordisk Investigational Site
Mesa, Arizona, 85213
Novo Nordisk Investigational Site
Miami, Florida, 33144
Novo Nordisk Investigational Site
Miami, Florida, 33145
Novo Nordisk Investigational Site
Miami, Florida, 33174
Novo Nordisk Investigational Site
Miami Lakes, Florida, 33016
Novo Nordisk Investigational Site
Mine Hill, New Jersey, 07803
Novo Nordisk Investigational Site
Mt. Pleasant, South Carolina, 29464
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, 29576
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
North Massapequa, New York, 11758-1802
Novo Nordisk Investigational Site
Northridge, California, 91324
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Pell City, Alabama, 35128
Novo Nordisk Investigational Site
Phoenix, Arizona, 85027
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Portland, Oregon, 97210
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
San Antonio, Texas, 78245
Novo Nordisk Investigational Site
San Diego, California, 92108
Novo Nordisk Investigational Site
Savannah, Georgia, 31406
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Whiteville, North Carolina, 28472

Other trials in United States

Netherlands9 sites

Novo Nordisk Investigational Site
Amsterdam, 1066 EC
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Delft, 2625 AD
Novo Nordisk Investigational Site
Hoofddorp, 2134 TM
Novo Nordisk Investigational Site
Leeuwarden, 8934 AD
Novo Nordisk Investigational Site
Rotterdam, 3021 HC
Novo Nordisk Investigational Site
Rotterdam, 3039 BD
Novo Nordisk Investigational Site
Venlo, 5912 BL
Novo Nordisk Investigational Site
Zoetermeer, 2725 NA

Other trials in Netherlands

France8 sites

Novo Nordisk Investigational Site
Châlons-en-Champagne, 51005
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Roubaix, 59100
Novo Nordisk Investigational Site
Strasbourg, 67000
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Germany8 sites

Novo Nordisk Investigational Site
Dresden, 01219
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Duisburg, 47051
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Mannheim, 68163
Novo Nordisk Investigational Site
Oldenburg, 23758
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Völklingen, 66333

Other trials in Germany

Italy7 sites

Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Città di Castello, 06012
Novo Nordisk Investigational Site
Milan, 20132
Novo Nordisk Investigational Site
Palermo, 90127
Novo Nordisk Investigational Site
Pavia, 27100
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Siena, 53100

Other trials in Italy

Greece6 sites

Novo Nordisk Investigational Site
Athens, GR-12462
Novo Nordisk Investigational Site
Athens, GR-14233
Novo Nordisk Investigational Site
Athens, GR-17562
Novo Nordisk Investigational Site
Piraeus, GR-18536
Novo Nordisk Investigational Site
Thessaloniki, GR-54636
Novo Nordisk Investigational Site
Thessaloniki, GR-57010

Other trials in Greece

United Kingdom6 sites

Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Bath, BA1 3NG
Novo Nordisk Investigational Site
Bradford on Avon, BA15 1DQ
Novo Nordisk Investigational Site
Haxey, DN9 2HY
Novo Nordisk Investigational Site
Headington, OX3 7LE
Novo Nordisk Investigational Site
Rotherham, S651DA

Other trials in United Kingdom

Argentina5 sites

Novo Nordisk Investigational Site
Buenos Aires, C1250AAN
Novo Nordisk Investigational Site
Buenos Aires, C1425AGC
Novo Nordisk Investigational Site
CABA, C1179AAB
Novo Nordisk Investigational Site
Lanús Este, B1824KAJ
Novo Nordisk Investigational Site
Mar del Plata, B7600GWV

Other trials in Argentina

Croatia5 sites

Novo Nordisk Investigational Site
Karlovac, 47000
Novo Nordisk Investigational Site
Osijek, 31 000
Novo Nordisk Investigational Site
Slavonski Brod, 35 000
Novo Nordisk Investigational Site
Virovitica, 33000
Novo Nordisk Investigational Site
Zagreb, 10 000

Other trials in Croatia

Finland5 sites

Novo Nordisk Investigational Site
Helsinki, 00260
Novo Nordisk Investigational Site
Helsinki, FI-00100
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Oulu, 90220
Novo Nordisk Investigational Site
Turku, 20520

Other trials in Finland

Switzerland5 sites

Novo Nordisk Investigational Site
Basel, 4031
Novo Nordisk Investigational Site
Geneva, 1211
Novo Nordisk Investigational Site
Lucerne, 6000
Novo Nordisk Investigational Site
Sankt Gallen, 9007
Novo Nordisk Investigational Site
Zollikerberg, 8125

Other trials in Switzerland

Serbia4 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Belgrade, 11080
Novo Nordisk Investigational Site
Kragujevac, 34000
Novo Nordisk Investigational Site
Novi Sad, 21000

Other trials in Serbia

Puerto Rico2 sites

Novo Nordisk Investigational Site
Caguas, 00725
Novo Nordisk Investigational Site
Manati, 00674

Other trials in Puerto Rico

About this study

Official title: 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)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: semaglutide, exenatide
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

semaglutideDrug
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
exenatideDrug
Also called Bydureon®
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly

Study groups in NCT01885208
Study group	Role	What they receive
Semaglutide 1.0 mg	Experimental	Not described Receives: Drug: semaglutide
Exenatide ER 2.0 mg	Active comparator	Not described Receives: Drug: exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Mean change in HbA1c from baseline to week 56.
Measured: Week 0, week 56

Secondary outcomes (5)

Change From Baseline in Body Weight
Mean change in body weight from baseline to week 56.
Measured: Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
Mean change in FPG from baseline to week 56.
Measured: Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
Mean changes in systolic and diastolic blood pressure from baseline to week 56.
Measured: Week 0, week 56
Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)
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.
Measured: 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)
The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.
Measured: After 56 weeks' treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201313 Jul 2015

First posted24 Jun 2013 (estimated)
Study start2 Dec 2013
Primary completion13 Jul 2015
Study completion13 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 813 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01885208
Sponsor's protocol ID: NN9535-3624
Other IDs: 2012-004826-92, U1111-1135-8647
Acronym: SUSTAIN™ 3
Status last verified: May 2019
First submitted: 20 Jun 2013
Last updated: 13 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.
PubMed 30938762
Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
PubMed 30865526
Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.
PubMed 29246950
Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
PubMed 29687620
Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
PubMed 29748996
Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.
PubMed 29766634
DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.
PubMed 29862621
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
PubMed 29907893
Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.
PubMed 30535837
Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
PubMed 30615985
Overgaard RV, Lindberg SO, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.
PubMed 30047216
Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.
PubMed 36056351
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
PubMed 32998732
Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.
PubMed 32827435
Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.
PubMed 32193837

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01885208
Acronym / sponsor ID: SUSTAIN™ 3 / NN9535-3624
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 813 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 2 Dec 2013 (actual)
Primary completion: 13 Jul 2015 (actual)
Study completion: 13 Jul 2015 (actual)
First posted: 24 Jun 2013 (estimated)
Results: Posted 30 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Semaglutide 1.0 mg	Experimental	Drug: semaglutide
Exenatide ER 2.0 mg	Active comparator	Drug: exenatide

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
semaglutideOne dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly	Drug	Semaglutide 1.0 mg
exenatideAlso: Bydureon®One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly	Drug	Exenatide ER 2.0 mg

Primary outcome

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

5 secondary outcomes

Change From Baseline in Body Weight
Time frame: Week 0, week 56
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 56
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: 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
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

Results and safety

Results posted to the registry on 30 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide 1.0 mg	406	374
Exenatide ER 2.0 mg	407	369

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, week 56. Least squares mean (Standard Error). Unit: percentage of glycosylated haemoglobin

Measure	Semaglutide 1.0 mg n = 404	Exenatide ER 2.0 mg n = 405
Value	-1.54 (0.06)	-0.92 (0.06)

Semaglutide 1.0 mg vs Exenatide ER 2.0 mg: Treatment difference: -0.62 (95% CI -0.8 to -0.44), p < 0.0001, Mixed Models Analysis
Semaglutide 1.0 mg vs Exenatide ER 2.0 mg: Treatment difference: -0.62 (95% CI -0.8 to -0.44), p < 0.0001, Mixed Models Analysis

Population analysed: The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events are treatment-emergent adverse events (TEAEs). A TEAE included events that had onset date (or increase in severity) on or after the first day of exposure (week 0) to randomised treatment (week 0-56 treatment period) and no later than the date of last dose + 42 days of follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sema 1.0 mg	38 of 404 (9.4%)	194 of 404 (48%)	Not reported
Exenatide ER	24 of 405 (5.9%)	187 of 405 (46.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30938762Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.
Background: PubMed 30865526Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
Results publication: PubMed 29246950Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.
Results publication: PubMed 29687620Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
Results publication: PubMed 29748996Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.
Results publication: PubMed 29766634Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.
Results publication: PubMed 29862621DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.
Results publication: PubMed 29907893Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.
Results publication: PubMed 30535837Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.
Results publication: PubMed 30615985Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
Results publication: PubMed 30047216Overgaard RV, Lindberg SO, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.
Derived from this study: PubMed 36056351Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

146 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide and exenatide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 146 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Netherlands, France, Germany, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01885208, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.