Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01720446
First received: October 29, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from randomisation to first occurrence of an expanded composite cardiovascular outcome [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ] [ Designated as safety issue: No ]
  • Time from randomisation to each individual component of the expanded composite cardiovascular outcome [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ] [ Designated as safety issue: No ]
  • Time from randomisation to first occurrence of all-cause death, non-fatal MI, or non-fatal stroke [ Time Frame: Time from randomisation up to end of follow-up (up to max. 148 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: lipid profile [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: urinary albumin to creatinine ratio [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: vital signs [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]
  • Incidence during the treatment period in other treatment outcomes: hypoglycaemic events [ Time Frame: Week 0 - 143 ] [ Designated as safety issue: No ]
  • Incidence during the treatment period in other treatment outcomes: adverse events [ Time Frame: Weeks 0-143 ] [ Designated as safety issue: No ]
  • Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies [ Time Frame: Weeks 0-143 ] [ Designated as safety issue: No ]
  • Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO) [ Time Frame: Week 0, up to week 143 ] [ Designated as safety issue: No ]

Enrollment: 3297
Study Start Date: February 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Semaglutide 0.5 mg Drug: semaglutide
Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c. under the skin)
Experimental: Semaglutide 1.0 mg Drug: semaglutide
Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
Placebo Comparator: Semaglutide placebo 0.5 mg Drug: placebo

Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment.

Administered subcutaneously (s.c., under the skin).

Placebo Comparator: Semaglutide placebo 1.0 mg Drug: placebo

Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment.

Administered subcutaneously (s.c., under the skin).


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with type 2 diabetes mellitus
  • Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease
  • Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs
  • HbA1c above or equal to 7.0% at screening

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
  • Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening
  • Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
  • Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Acute coronary or cerebro-vascular event within 90 days prior to randomisation
  • Currently planned coronary, carotid or peripheral artery revascularisation
  • Chronic heart failure New York Heart Association (NYHA) class IV
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
  • Personal history of non-familial medullary thyroid carcinoma
  • Screening calcitonin above or equal to 50 ng/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720446

  Show 107 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720446     History of Changes
Other Study ID Numbers: NN9535-3744, 2012-002839-28, U1111-1131-7227
Study First Received: October 29, 2012
Last Updated: May 15, 2014
Health Authority: Algeria: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Public Health Agency of Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Poland: Ministry of Health and Social Security
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines and Health Care Products
Taiwan: Department of Health
Thailand: Ministry of Public Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014