A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01018173
First received: November 20, 2009
Last updated: October 6, 2014
Last verified: October 2014

November 20, 2009
October 6, 2014
January 2010
January 2011   (final data collection date for primary outcome measure)
Time to cardiovascular composite primary endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018173 on ClinicalTrials.gov Archive Site
  • Secondary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
  • Individual components of primary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
  • Total mortality [ Time Frame: assessed at end of study, week 104 ] [ Designated as safety issue: No ]
  • Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, ACR, albuminuria, GFR [ Time Frame: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease

This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspogluti de subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or we ekly sc placebo, in addition to background anti-hyperglycemic medication and sta ndard of care treatment for cardiovascular disease. Anticipated time on study tr eatment is up to 2 years. Target sample size is 2000 patients.

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 Mellitus, Type 2
  • Drug: placebo
    sc weekly
  • Drug: taspoglutide
    10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
  • Experimental: 1
    Intervention: Drug: taspoglutide
  • Placebo Comparator: 2
    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.
 
Completed
2118
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >18 years of age
  • diabetes mellitus type 2
  • HbA1c >/=6.5% and </=10% at screening
  • BMI >/=23kg/m2
  • cardiovascular disease with onset >/=1 month prior to screening

Exclusion Criteria:

  • diagnosis or history of type 1 diabetes or secondary forms of diabetes
  • acute metabolic diabetic complications within past 6 months
  • severe hypoglycemia </=1 month prior to screening
  • clinically significant gastrointestinal disease
  • history of chronic or acute pancreatitis
  • current NYHA class IV heart failure or post-transplantation cardiomyopathy
  • severely impaired renal function
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Australia,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Estonia,   United Kingdom,   Hungary,   India,   Israel,   Lithuania,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Ukraine
 
NCT01018173
NC25113, 2009-014986-22
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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