A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Investigate the Effect of Taspoglutide on Gastric Emptying Measured by a Paracetamol Test After Single Dose and After Multiple Doses in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809705
• Other study ID #: BP21572
• Secondary ID: 2008-003575-47
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: November 1, 2016
• Start date: December 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• 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 mellitus, treated with stable oral antidiabetic drug therapy for >=3 months prior to screening;

• stable weight +/-10% for >=3 months before screening.

Exclusion Criteria:

• type 1 diabetes mellitus;

• acute gastrointestinal symptoms at screening and/or day -1;

• clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.

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 for 12 weeks
• taspoglutide
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks
• taspoglutide
10mg sc once weekly for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tmax, log (AUC), log(Cmax)of paracetamol		Days -1, 1, 5, 29, 33, 78 and 82	No
Secondary	Adverse events, laboratory parameters, vital signs		Throughout study	No
Secondary	renal function (creatinine clearance, urine volume and electrolytes)		Throughout study	No
Secondary	Multiple dose pharmacokinetics of Taspoglutide		Throughout study	No