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DiabetesPhase 3SUSTAIN™1NCT02054897

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

A Phase 3 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 sites in 9 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 globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy). 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
388 participants
Where
86 sitesin 9 countries
Study dates
3 Feb 2014to 8 May 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: - For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - 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 is of child-bearing potential and 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. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - 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 any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) below 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

Trial locations and contacts

86 sites in 9 countries.

86 sites in 9 countries

United States38 sites

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87102

  • Novo Nordisk Investigational Site

    Anniston, Alabama, 36207

  • Novo Nordisk Investigational Site

    Belvidere, New Jersey, 07823

  • Novo Nordisk Investigational Site

    Billings, Montana, 59101

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35216

  • Novo Nordisk Investigational Site

    Boynton Beach, Florida, 33472

  • Novo Nordisk Investigational Site

    Brownsburg, Indiana, 46112

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45255

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80920

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Delaware, Ohio, 43015

  • Novo Nordisk Investigational Site

    Franklin, Indiana, 46131

  • Novo Nordisk Investigational Site

    Hawaiian Gardens, California, 90716

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32277

  • Novo Nordisk Investigational Site

    Levittown, Pennsylvania, 19056

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40504

  • Novo Nordisk Investigational Site

    Lomita, California, 90717

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Miami, Florida, 33015

  • Novo Nordisk Investigational Site

    Miami, Florida, 33143

  • Novo Nordisk Investigational Site

    Miami, Florida, 33144

  • Novo Nordisk Investigational Site

    Miami, Florida, 33173

  • Novo Nordisk Investigational Site

    Miami, Florida, 33174

  • Novo Nordisk Investigational Site

    Miami Lakes, Florida, 33016

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Northridge, California, 91324

  • Novo Nordisk Investigational Site

    Olive Branch, Mississippi, 38654

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68144

  • Novo Nordisk Investigational Site

    Pell City, Alabama, 35128

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33026

  • Novo Nordisk Investigational Site

    Savannah, Georgia, 31406

  • Novo Nordisk Investigational Site

    Sealy, Texas, 77474

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina, 29303

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77479

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina, 28472

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67226

Other trials in United States

Russia9 sites

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163001

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045

  • Novo Nordisk Investigational Site

    Chelyabinsk, 454048

  • Novo Nordisk Investigational Site

    Kazan', 420073

  • Novo Nordisk Investigational Site

    Novosibirsk, 630047

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194358

  • Novo Nordisk Investigational Site

    Saint-Petesburg, 195257

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Stavropol, 355035

Other trials in Russia

South Africa9 sites

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State, 9301

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4450

  • Novo Nordisk Investigational Site

    eMkhomazi, KwaZulu-Natal, 4170

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1818

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1827

  • Novo Nordisk Investigational Site

    Krugersdorp, Gauteng, 1739

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6014

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0084

  • Novo Nordisk Investigational Site

    Vrededorp, Gauteng, 2129

Other trials in South Africa

Canada7 sites

  • Novo Nordisk Investigational Site

    London, Ontario, N6P 1A9

  • Novo Nordisk Investigational Site

    Montreal, Quebec, H4A 3T2

  • Novo Nordisk Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M3J 1N2

  • Novo Nordisk Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • Novo Nordisk Investigational Site

    Vancouver, British Columbia, V6J 1S3

  • Novo Nordisk Investigational Site

    Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

Italy6 sites

  • Novo Nordisk Investigational Site

    Catania, 95122

  • Novo Nordisk Investigational Site

    Pisa, 56124

  • Novo Nordisk Investigational Site

    Roma, 00133

  • Novo Nordisk Investigational Site

    Rome, 00168

  • Novo Nordisk Investigational Site

    Siena, 53100

  • Novo Nordisk Investigational Site

    Terni, 05100

Other trials in Italy

Japan5 sites

  • Novo Nordisk Investigational Site

    Kyoto-shi, Kyoto, 606-8507

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka, 565-0853

  • Novo Nordisk Investigational Site

    Tokyo, 103-0027

  • Novo Nordisk Investigational Site

    Tokyo, 103-0028

  • Novo Nordisk Investigational Site

    Tokyo, 160-0008

Other trials in Japan

Romania5 sites

  • Novo Nordisk Investigational Site

    Bucharest, 010507

  • Novo Nordisk Investigational Site

    Bucharest, 13682

  • Novo Nordisk Investigational Site

    Buzău, 120203

  • Novo Nordisk Investigational Site

    Galati, 800578

  • Novo Nordisk Investigational Site

    Oradea, Bihor County, 410469

Other trials in Romania

United Kingdom4 sites

  • Novo Nordisk Investigational Site

    Cardiff, CF5 4AD

  • Novo Nordisk Investigational Site

    Dundee, DD2 5NH

  • Novo Nordisk Investigational Site

    St Helens, WA9 3DA

  • Novo Nordisk Investigational Site

    Swansea, SA2 8PP

Other trials in United Kingdom

Mexico3 sites

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Ciudad Madero, Tamaulipas, 89440

  • Novo Nordisk Investigational Site

    Monterrey, Nuevo León, 64620

Other trials in Mexico

About this study

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

Being tested
semaglutide, placebo
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

    Once weekly, administrated subcutaneously (s.c. under the skin)

  • placeboDrug

    Once weekly, administrated subcutaneously (s.c. under the skin)

Study groups in NCT02054897
Study groupRoleWhat they receive
Semaglutide 1.0 mgExperimentalNot described
Receives: Drug: semaglutide
Semaglutide 0.5 mgExperimentalNot described
Receives: Drug: semaglutide
Semaglutide placebo 1.0 mgPlacebo comparatorNot described
Receives: Drug: placebo
Semaglutide placebo 0.5 mgPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

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

  1. Change in HbA1c (Glycosylated Haemoglobin)

    Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

    Measured: Week 0, week 30

Secondary outcomes (5)

  1. Change in Body Weight

    Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

    Measured: Week 0, week 30

  2. Change in Fasting Plasma Glucose (FPG)

    Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

    Measured: Week 0, week 30

  3. Change in Systolic and Diastolic Blood Pressure

    Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.

    Measured: Week 0, week 30

  4. Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target

    Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c 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.

    Measured: At 30 weeks of treatment

  5. Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target

    Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c 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.

    Measured: At 30 weeks of treatment

Timeline

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

  1. First posted4 Feb 2014 (estimated)
  2. Study start3 Feb 2014
  3. Primary completion8 May 2015
  4. Study completion8 May 2015

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02054897
Sponsor's protocol ID
NN9535-3623
Other IDs
2013-000632-94, U1111-1139-3090, JapicCTI-142442
Acronym
SUSTAIN™1
Status last verified
May 2019
First submitted
3 Feb 2014
Last updated
12 Jun 2019
Data monitoring committee
No

Publications

  • 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

  • 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

  • Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbol JD, Hansen T, Bain SC. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017 Apr;5(4):251-260. doi: 10.1016/S2213-8587(17)30013-X. Epub 2017 Jan 17.

    PubMed 28110911

  • 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

  • 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

  • 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

  • Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

    PubMed 31903692

  • DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

    PubMed 31769496

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 86 sites in 9 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 12 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 86 sites in United States, Russia, South Africa, Canada, Italy and 4 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. Some participants in this study may receive a placebo. 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 23 Jan 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 in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 30). 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 NCT02054897, which also lists 13 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 12 Jun 2019.

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