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

Roche

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: taspoglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809705

2008-003575-47

BP21572

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

2

Experimental group

Treatment:

Drug: taspoglutide

Drug: taspoglutide

3

Placebo Comparator group

Treatment:

Drug: Placebo