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

NCT02054897 | Completed Phase 3 Results

• 4 other identifiers: NN9535-36232013-000632-94U1111-1139-3090JapicCTI-142442
• Study Type: interventional
• Target: 388
• Locations: 9 countries
• Sites: 86

Brief 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).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

  Week 0, week 30

Secondary Outcomes (5)

• Change in Body Weight

  Week 0, week 30

• Change in Fasting Plasma Glucose (FPG)

  Week 0, week 30

• Change in Systolic and Diastolic Blood Pressure

  Week 0, week 30

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

  At 30 weeks of treatment

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

  At 30 weeks of treatment

Study Arms (4)

Semaglutide 1.0 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 0.5 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide placebo 1.0 mg

PLACEBO COMPARATOR

Drug: placebo

Semaglutide placebo 0.5 mg

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutide DRUG

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

Semaglutide 0.5 mg; Semaglutide 1.0 mg

placebo DRUG

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

Semaglutide placebo 0.5 mg; Semaglutide placebo 1.0 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (86)

Novo Nordisk Investigational Site

Anniston, Alabama, 36207, United States

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Birmingham, Alabama, 35216, United States

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Pell City, Alabama, 35128, United States

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Hawaiian Gardens, California, 90716, United States

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Lomita, California, 90717, United States

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Los Angeles, California, 90057, United States

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Montclair, California, 91763, United States

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Northridge, California, 91324, United States

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Colorado Springs, Colorado, 80920, United States

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Boynton Beach, Florida, 33472, United States

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Jacksonville, Florida, 32277, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33173, United States

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Miami, Florida, 33174, United States

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Miami Lakes, Florida, 33016, United States

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Pembroke Pines, Florida, 33026, United States

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Savannah, Georgia, 31406, United States

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Brownsburg, Indiana, 46112, United States

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Franklin, Indiana, 46131, United States

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Wichita, Kansas, 67226, United States

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Lexington, Kentucky, 40504, United States

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Olive Branch, Mississippi, 38654, United States

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Billings, Montana, 59101, United States

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Omaha, Nebraska, 68144, United States

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Belvidere, New Jersey, 07823, United States

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Albuquerque, New Mexico, 87102, United States

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Charlotte, North Carolina, 28277, United States

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Whiteville, North Carolina, 28472, United States

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Cincinnati, Ohio, 45255, United States

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Delaware, Ohio, 43015, United States

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Levittown, Pennsylvania, 19056, United States

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Spartanburg, South Carolina, 29303, United States

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Dallas, Texas, 75230, United States

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Sealy, Texas, 77474, United States

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Sugar Land, Texas, 77478, United States

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Sugar Land, Texas, 77479, United States

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Vancouver, British Columbia, V6J 1S3, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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London, Ontario, N6P 1A9, Canada

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Toronto, Ontario, M3J 1N2, Canada

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Montreal, Quebec, H4A 3T2, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Catania, 95122, Italy

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Pisa, 56124, Italy

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Roma, 00133, Italy

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Rome, 00168, Italy

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Siena, 53100, Italy

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Terni, 05100, Italy

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Kyoto-shi, Kyoto, 606-8507, Japan

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Suita-shi, Osaka, 565-0853, Japan

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Tokyo, 103-0027, Japan

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Tokyo, 103-0028, Japan

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Tokyo, 160-0008, Japan

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Monterrey, Nuevo León, 64620, Mexico

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Ciudad Madero, Tamaulipas, 89440, Mexico

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Aguascalientes, 20230, Mexico

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Oradea, Bihor County, 410469, Romania

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Bucharest, 010507, Romania

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Bucharest, 13682, Romania

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Buzău, 120203, Romania

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Galati, 800578, Romania

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Arkhangelsk, 163001, Russia

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Arkhangelsk, 163045, Russia

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Novo Nordisk Investigational Site

Chelyabinsk, 454048, Russia

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Kazan', 420073, Russia

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Novosibirsk, 630047, Russia

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Saint Petersburg, 194358, Russia

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Saint-Petesburg, 195257, Russia

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Saratov, 410053, Russia

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Stavropol, 355035, Russia

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Port Elizabeth, Eastern Cape, 6014, South Africa

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Bloemfontein, Free State, 9301, South Africa

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Johannesburg, Gauteng, 1818, South Africa

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Johannesburg, Gauteng, 1827, South Africa

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Krugersdorp, Gauteng, 1739, South Africa

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Pretoria, Gauteng, 0084, South Africa

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Vrededorp, Gauteng, 2129, South Africa

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Durban, KwaZulu-Natal, 4450, South Africa

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Novo Nordisk Investigational Site

eMkhomazi, KwaZulu-Natal, 4170, South Africa

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Cardiff, CF5 4AD, United Kingdom

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Dundee, DD2 5NH, United Kingdom

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St Helens, WA9 3DA, United Kingdom

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Swansea, SA2 8PP, United Kingdom

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Related Publications (13)

• 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.

  PMID: 30047216 BACKGROUND

• 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.

  PMID: 30938762 BACKGROUND

• 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.

  PMID: 30865526 BACKGROUND

• 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.

  PMID: 28110911 RESULT

• 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.

  PMID: 29687620 RESULT

• 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.

  PMID: 29748996 RESULT

• 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.

  PMID: 29766634 RESULT

• 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.

  PMID: 29862621 RESULT

• 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.

  PMID: 29907893 RESULT

• 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.

  PMID: 30615985 RESULT

• 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.

  PMID: 32998732 DERIVED

• 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.

  PMID: 31903692 DERIVED

• 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.

  PMID: 31769496 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: February 3, 2014
• Primary Completion: May 8, 2015
• Study Completion: May 8, 2015
• Last Updated: June 12, 2019
• Results First Posted: January 23, 2018

Record last verified: 2019-05

Locations

US (38); GB (4); CA (7); ME (3); IT (6); JP (5); RU (9); ZA (9); RO (5)