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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018173
• Other study ID #: NC25113
• Secondary ID: 2009-014986-22
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2009
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2118
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• placebo
sc weekly
• taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Estonia,  Germany,  Hungary,  India,  Israel,  Lithuania,  Malaysia,  Mexico,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to cardiovascular composite primary endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter	No
Secondary	Secondary cardiovascular composite endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter	No
Secondary	Individual components of primary cardiovascular composite endpoints		event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter	No
Secondary	Total mortality		assessed at end of study, week 104	No
Secondary	Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR)		laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter	No