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Trial record 1 of 919 for:    SUSTAIN 5
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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 (SUSTAIN™ 5)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02305381
First Posted: December 2, 2014
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 30 ]

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: Week 0, week 30 ]
  • Change in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 30 ]
  • Change in insulin dose [ Time Frame: Week 0, week 30 ]
  • Change in systolic and diastolic blood pressure [ Time Frame: Week 0, week 30 ]
  • Patient reported outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Week 0, week 30 ]
  • HbA1c below 7.0% (53 mmol/mol) American Diabetes Association (ADA) target [ Time Frame: After 30 weeks treatment ]
  • HbA1c below or equal to 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target [ Time Frame: After 30 weeks treatment ]

Enrollment: 397
Study Start Date: December 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semaglutide 0.5 mg/Week Drug: semaglutide
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
Experimental: Semaglutide 1.0 mg/Week Drug: semaglutide
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
Placebo Comparator: Semaglutide Placebo 0.5 mg/Week Drug: placebo
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
Placebo Comparator: Semaglutide Placebo 1.0 mg/Week Drug: placebo
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 - 10.0 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305381


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85018
United States, California
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Lomita, California, United States, 90717
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057-3550
Novo Nordisk Investigational Site
Northridge, California, United States, 91325
Novo Nordisk Investigational Site
Poway, California, United States, 92064
Novo Nordisk Investigational Site
Riverside, California, United States, 92506
Novo Nordisk Investigational Site
Roseville, California, United States, 95661
Novo Nordisk Investigational Site
San Ramon, California, United States, 94583
Novo Nordisk Investigational Site
Van Nuys, California, United States, 91405
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Connecticut
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Brooksville, Florida, United States, 34601
Novo Nordisk Investigational Site
Fleming Island, Florida, United States, 32003
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32204
Novo Nordisk Investigational Site
Port Charlotte, Florida, United States, 33952
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33634
United States, Georgia
Novo Nordisk Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60611
Novo Nordisk Investigational Site
Gillespie, Illinois, United States, 62033
Novo Nordisk Investigational Site
Skokie, Illinois, United States, 60077
United States, Indiana
Novo Nordisk Investigational Site
Avon, Indiana, United States, 46123
Novo Nordisk Investigational Site
Greenfield, Indiana, United States, 46140
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Iowa
Novo Nordisk Investigational Site
Council Bluffs, Iowa, United States, 51501
United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66209
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Investigational Site
Lexington, Kentucky, United States, 40503
Novo Nordisk Investigational Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
Novo Nordisk Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Waltham, Massachusetts, United States, 02453
United States, Michigan
Novo Nordisk Investigational Site
Ann Arbor, Michigan, United States, 48106
Novo Nordisk Investigational Site
Flint, Michigan, United States, 48532
Novo Nordisk Investigational Site
Kalamazoo, Michigan, United States, 49009
United States, Mississippi
Novo Nordisk Investigational Site
Jackson, Mississippi, United States, 39209
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89103
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Novo Nordisk Investigational Site
Teaneck, New Jersey, United States, 07666
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45245
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45246
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45439
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73162-4704
Novo Nordisk Investigational Site
Yukon, Oklahoma, United States, 73099
United States, Pennsylvania
Novo Nordisk Investigational Site
Levittown, Pennsylvania, United States, 19056-2404
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19152
United States, Tennessee
Novo Nordisk Investigational Site
Athens, Tennessee, United States, 37303
Novo Nordisk Investigational Site
Bristol, Tennessee, United States, 37620-7352
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States, 37411
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Amarillo, Texas, United States, 79106
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75251
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76132
Novo Nordisk Investigational Site
Houston, Texas, United States, 77008
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
Novo Nordisk Investigational Site
Katy, Texas, United States, 77450
Novo Nordisk Investigational Site
Mesquite, Texas, United States, 75149
Novo Nordisk Investigational Site
Pasadena, Texas, United States, 77504
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Bountiful, Utah, United States, 84010
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
United States, Wisconsin
Novo Nordisk Investigational Site
Kenosha, Wisconsin, United States, 53142
Germany
Novo Nordisk Investigational Site
Essen, Germany, 45219
Novo Nordisk Investigational Site
Falkensee, Germany, 14612
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Hamburg, Germany, 21073
Novo Nordisk Investigational Site
Hamburg, Germany, 22587
Novo Nordisk Investigational Site
Hamburg, Germany, 22607
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Münster, Germany, 48145
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Stuttgart, Germany, 70378
Novo Nordisk Investigational Site
Sulzbach-Rosenberg, Germany, 92237
Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582 0005
Novo Nordisk Investigational Site
Kumamoto, Japan
Novo Nordisk Investigational Site
Miyazaki-shi, Japan, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
Novo Nordisk Investigational Site
Takatsuki-shi, Osaka, Japan, 569 1096
Puerto Rico
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Kragujevac, Serbia, 34000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Slovakia
Novo Nordisk Investigational Site
Bratislava, Slovakia, 833 05
Novo Nordisk Investigational Site
Kosice, Slovakia, 040 01
Novo Nordisk Investigational Site
Levice, Slovakia, 93401
Novo Nordisk Investigational Site
Lucenec, Slovakia, 984 01
Novo Nordisk Investigational Site
Presov, Slovakia, 080 01
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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.

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02305381     History of Changes
Other Study ID Numbers: NN9535-3627
2013-004502-26 ( EudraCT Number )
U1111-1149-3738 ( Other Identifier: WHO )
JapicCTI-142729 ( Other Identifier: JAPIC )
First Submitted: November 28, 2014
First Posted: December 2, 2014
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs