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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018173

Enrollment

2118

Registered

2009-11-23

Start date

2010-01-31

Completion date

2011-01-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGplacebo

sc weekly

DRUGtaspoglutide

10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to cardiovascular composite primary endpoints	event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Secondary

Measure	Time frame
Secondary cardiovascular composite endpoints	event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Individual components of primary cardiovascular composite endpoints	event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
Total mortality	assessed at end of study, week 104
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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026