Loading clinical trials...

A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01018173•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (288)

Phoenix, Arizona, United States

Tucson, Arizona, United States

Buena Park, California, United States

Calabasas, California, United States

Fresno, California, United States

Santa Ana, California, United States

Walnut Creek, California, United States

Centennial, Colorado, United States

Colorado Springs, Colorado, United States

Trumbull, Connecticut, United States

Key Dates

Start Date

January 1, 2010

Primary Completion Date

January 1, 2011

Completion Date

January 1, 2011

Last Updated

November 2, 2016

Enrollment

2,118

ACTUAL participants

Conditions

Diabetes Mellitus Type 2

Interventions

placebo

DRUG

taspoglutide

DRUG

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

NCT06525259

Diabetes Mellitus Type 2, Childhood-Onset

View study

RECRUITINGNA

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

NCT07011147

Type 1 Diabetes (T1D)Type 2 Diabetes+9 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

DISCOVERY of Risk Factors for Type 2 Diabetes in Youth

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Impact of Long Alimentary Limb or Long Biliary Limb Roux-en-Y Gastric Bypass on Type 2 Diabetes Remission in Severely Obese Patients.

Therapeutic Efficacy and Safety Evaluation of AI in the Management of Diabetes: A RCT Trial

The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients

App-based Diabetes Management and Community-based Interventions