A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00717457

Enrollment

1189

Registered

2008-07-17

Start date

2008-07-31

Completion date

2011-03-31

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 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.

Interventions

DRUGexenatide

5mg twice daily for 4 weeks followed by 10mg twice daily

DRUGtaspoglutide

10mg once weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years of age; * type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks; * HbA1c \>=7.0% and \<=10% at screening; * BMI \>=25kg/m2 (\>23kg/m2 for Asians) and \<=45kg/m2 at screening; * stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion criteria

* history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes; * history of acute metabolic diabetic complications within the previous 6 months; * evidence of clinically significant diabetic complications; * known proliferative diabetic retinopathy; * myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months; * any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator; * known hemoglobinopathy or chronic anemia; * clinically significant gastrointestinal disease.

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	24 weeks

Secondary

Measure	Time frame
Fasting body weight	24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%	24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.	24 weeks
Beta cell function (proinsulin/insulin ratio)	24 weeks

Countries

Argentina, Australia, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Guatemala, Israel, Italy, Mexico, New Zealand, Peru, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, United States

Outcome results

None listed

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