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Trial record 1 of 912 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


  Show 99 Study Locations
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