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

NCT ID: NCT02054897

Last Updated: 2019-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-03

Study Completion Date

2015-05-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide 1.0 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

Semaglutide 0.5 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

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

Semaglutide placebo 1.0 mg

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Semaglutide placebo 0.5 mg

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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semaglutide

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Anniston, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Novo Nordisk Investigational Site

Pell City, Alabama, United States

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Hawaiian Gardens, California, United States

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Novo Nordisk Investigational Site

Lomita, California, United States

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Los Angeles, California, United States

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Novo Nordisk Investigational Site

Montclair, California, United States

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Northridge, California, United States

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Colorado Springs, Colorado, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Pembroke Pines, Florida, United States

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Savannah, Georgia, United States

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Brownsburg, Indiana, United States

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Franklin, Indiana, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Olive Branch, Mississippi, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Belvidere, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Whiteville, North Carolina, United States

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Cincinnati, Ohio, United States

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Delaware, Ohio, United States

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Levittown, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Dallas, Texas, United States

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Sealy, Texas, United States

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Sugar Land, Texas, United States

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Sugar Land, Texas, United States

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Catania, , Italy

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Pisa, , Italy

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Roma, , Italy

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Rome, , Italy

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Siena, , Italy

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Terni, , Italy

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Kyoto-shi, Kyoto, , Japan

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Novo Nordisk Investigational Site

Suita-shi, Osaka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Monterrey, Nuevo León, Mexico

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Ciudad Madero, Tamaulipas, Mexico

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Aguascalientes, , Mexico

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Novo Nordisk Investigational Site

Oradea, Bihor County, Romania

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Novo Nordisk Investigational Site

Bucharest, , Romania

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Bucharest, , Romania

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Buzău, , Romania

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Galati, , Romania

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Arkhangelsk, , Russia

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Arkhangelsk, , Russia

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Chelyabinsk, , Russia

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Kazan', , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saint-Petesburg, , Russia

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Saratov, , Russia

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Stavropol, , Russia

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Port Elizabeth, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Krugersdorp, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Vrededorp, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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eMkhomazi, KwaZulu-Natal, South Africa

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Cardiff, , United Kingdom

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Dundee, , United Kingdom

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St Helens, , United Kingdom

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Novo Nordisk Investigational Site

Swansea, , United Kingdom

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Countries

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United States Canada Italy Japan Mexico Romania Russia South Africa United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 30047216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30938762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30865526 (View on PubMed)

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.

Reference Type RESULT
PMID: 28110911 (View on PubMed)

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.

Reference Type RESULT
PMID: 29687620 (View on PubMed)

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.

Reference Type RESULT
PMID: 29748996 (View on PubMed)

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.

Reference Type RESULT
PMID: 29766634 (View on PubMed)

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.

Reference Type RESULT
PMID: 29862621 (View on PubMed)

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.

Reference Type RESULT
PMID: 29907893 (View on PubMed)

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.

Reference Type RESULT
PMID: 30615985 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31903692 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31769496 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2013-000632-94

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1139-3090

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142442

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-3623

Identifier Type: -

Identifier Source: org_study_id

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