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

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ClinicalTrials.gov Identifier: NCT01018173
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: placebo Drug: taspoglutide Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
sc weekly
Experimental: taspoglutide Drug: taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly


Outcome Measures

Primary Outcome Measures :
  1. Time to cardiovascular composite primary endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]

Secondary Outcome Measures :
  1. Secondary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
  2. Individual components of primary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
  3. Total mortality [ Time Frame: assessed at end of study, week 104 ]
  4. Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR) [ Time Frame: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter ]

Eligibility Criteria

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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:

  • 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 New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
  • severely impaired renal function
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): NCT01018173


  Show 288 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01018173     History of Changes
Other Study ID Numbers: NC25113
2009-014986-22
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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