Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes - Full Text View

Purpose

This trial is conducted globally. The aim of this 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) across 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:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 ]
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 ]

Estimated Enrollment:	3260
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
An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2 (week 0)
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

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

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Show 97 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Pernille Drewes

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
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:	April 19, 2013
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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