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: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2009

Last Updated Date

May 7, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01018173 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: taspoglutide
Placebo Comparator: 2
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2118

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT01018173

Other Study ID Numbers ^ICMJE

NC25113, 2009-014986-22

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

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

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