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Efficacy and Safety of Semagl...

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

NCT ID: NCT02305381

Last Updated: 2019-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2015-11-21

Brief Summary

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This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

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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 0.5 mg/Week

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Semaglutide 1.0 mg/Week

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Semaglutide Placebo 0.5 mg/Week

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Semaglutide Placebo 1.0 mg/Week

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Interventions

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semaglutide

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Intervention Type DRUG

placebo

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.

Exclusion Criteria

0 percent (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 an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents 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 bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - History of pancreatitis (acute or chronic) - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN 2) - Severe renal impairment 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 (NYHA) 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

Phoenix, Arizona, United States

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Anaheim, California, United States

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Fresno, California, United States

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Lomita, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Poway, California, United States

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Riverside, California, United States

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Roseville, California, United States

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San Ramon, California, United States

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Van Nuys, California, United States

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Walnut Creek, California, United States

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Waterbury, Connecticut, United States

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Bradenton, Florida, United States

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Fleming Island, Florida, United States

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Jacksonville, Florida, United States

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Port Charlotte, Florida, United States

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Spring Hill, Florida, United States

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Tampa, Florida, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Gillespie, Illinois, United States

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Skokie, Illinois, United States

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Avon, Indiana, United States

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Greenfield, Indiana, United States

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Indianapolis, Indiana, United States

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Muncie, Indiana, United States

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Council Bluffs, Iowa, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Paducah, Kentucky, United States

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Metairie, Louisiana, United States

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Rockville, Maryland, United States

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Waltham, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Flint, Michigan, United States

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Kalamazoo, Michigan, United States

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Jackson, Mississippi, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Teaneck, New Jersey, United States

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Albuquerque, New Mexico, United States

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West Seneca, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Yukon, Oklahoma, United States

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Levittown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Athens, Tennessee, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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Katy, Texas, United States

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Mesquite, Texas, United States

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San Antonio, 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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Bountiful, Utah, United States

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Richmond, Virginia, United States

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Kenosha, Wisconsin, United States

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Essen, , Germany

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Falkensee, , Germany

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Friedrichsthal, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hohenmölsen, , Germany

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Münster, , Germany

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Rehlingen-Siersburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Stuttgart, , Germany

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Sulzbach-Rosenberg, , Germany

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Ibaraki, , Japan

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Kashiwara-shi, Osaka, , Japan

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Kumamoto-shi, Kumamoto, , Japan

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Miyazaki, , Japan

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Osaka, , Japan

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Tokyo, , Japan

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Manatí, , Puerto Rico

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Novi Sad, , Serbia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Levice, , Slovakia

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Lučenec, , Slovakia

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Prešov, , Slovakia

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Countries

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United States Germany Japan Puerto Rico Serbia Slovakia

References

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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)

Rodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Diabetologia. 2016; 59: S364-5.

Reference Type RESULT

Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2291-2301. doi: 10.1210/jc.2018-00070.

Reference Type RESULT

PMID: 29688502 (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)

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)

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)

Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

Reference Type DERIVED

PMID: 31215727 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2013-004502-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1149-3738

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-142729

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-3627

Identifier Type: -

Identifier Source: org_study_id

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