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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: October 14, 2014
Last verified: October 2014

October 29, 2012
October 14, 2014
February 2013
January 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01720446 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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)
  • 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)
  • 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).

  • Experimental: Semaglutide 0.5 mg
    Intervention: Drug: semaglutide
  • Experimental: Semaglutide 1.0 mg
    Intervention: Drug: semaglutide
  • Placebo Comparator: Semaglutide placebo 0.5 mg
    Intervention: Drug: placebo
  • Placebo Comparator: Semaglutide placebo 1.0 mg
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3297
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Algeria,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Denmark,   Germany,   India,   Israel,   Italy,   Malaysia,   Mexico,   Poland,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01720446
NN9535-3744, 2012-002839-28, U1111-1131-7227
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP