A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754988
• Other study ID #: BC21713
• Secondary ID: 2008-001854-42
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2008
• Last updated: November 3, 2016
• Start date: October 2008
• Est. completion date: March 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 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 666
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-75 years of age;

• type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks;

• HbA1c >=7.0% and <=10.0% at screening;

• BMI >=25 (>23 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 mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;

• evidence of clinically significant diabetic complications;

• clinically symptomatic gastrointestinal disease;

• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;

• known hemoglobinopathy or chronic anemia.

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

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin
As prescribed
• Placebo (matching sitagliptin)
Once daily oral administration of placebo (matching sitagliptin).
• Placebo (matching taspoglutide)
Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
• Sitagliptin
Once daily oral administration of 100 mg of sitagliptin.
• Taspoglutide
Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Greece,  Korea, Republic of,  Mexico,  Norway,  Peru,  Poland,  Puerto Rico,  Romania,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean changes in HbA1c		24 weeks	No
Secondary	Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; change from baseline in lipid profile; beta cell function.		24 weeks	No
Secondary	Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.		Throughout study	No