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A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.

A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00460941
Enrollment
133
Registered
2007-04-17
Start date
2007-04-30
Completion date
2008-01-31
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 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Interventions

DRUGPlacebo

sc weekly

DRUGTaspoglutide 20mg

sc weekly

DRUGTaspoglutide 20mg-30mg

sc weekly

DRUGTaspoglutide 20mg-40mg

sc weekly

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age; * type 2 diabetes mellitus, with stable metformin treatment for \>=3 months; * HbA1c \>=7.0% and \<=9.5% at screening; * stable weight +/-10% for \>=3 months before screening.

Exclusion criteria

* type 1 diabetes mellitus; * clinically significant gastrointestinal disease; * treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months; * use of weight-lowering medications in the last 3 months; * uncontrolled hypertension; * previous exposure to GLP-1 or GLP-1 analogues.

Design outcomes

Primary

MeasureTime frame
Percentage of patients withdrawn because of gastrointestinal effectsWeek 9

Secondary

MeasureTime frame
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.Week 9

Countries

Australia, France, Germany, Mexico, Peru, Puerto Rico, United States

Outcome results

None listed

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