A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744926
• Other study ID #: BC20750
• Secondary ID: 2008-001765-28
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2008
• Last updated: July 26, 2016
• Start date: August 2008
• Est. completion date: April 2010

Study information

• Verified date: July 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 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks 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 1 year, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-80 years of age;

• drug naive patients with type 2 diabetes uncontrolled with diet and exercise;

• tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;

• C-peptide (fasting) >=1.0ng/mL

• HbA1c >=6.5% 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;

• symptomatic poorly controlled diabetes;

• 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:
• placebo
sc, once weekly
• taspoglutide
10mg sc, once weekly
• taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Guatemala,  Israel,  Mexico,  Peru,  Romania,  Russian Federation,  Slovakia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbA1c		24 weeks	No
Secondary	Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.		Throughout study	No
Secondary	Change from baseline in fasting plasma glucose; change from baseline in body weight.		24 weeks	No
Secondary	Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.		24 weeks	No