Clinical trial NCT00423501: A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Official title: A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* 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.

Primary outcomes:
measure: Absolute change from baseline in HbAlc
timeFrame: Week 8
Secondary outcomes:
measure: Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
timeFrame: Week 8
measure: Changes in lipid profile
timeFrame: Week 8
measure: AEs, laboratory parameters, primary pharmacokinetic parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Washington
country: United States
state: District of Columbia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Rochester
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Dimitrovgrad
country: Bulgaria
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Bad Lauterberg
country: Germany
city: Berlin
country: Germany
city: Görlitz
country: Germany
city: Hannover
country: Germany
city: Mainz
country: Germany
city: Neuss
country: Germany
city: Nürnberg
country: Germany
city: Guatemala City
country: Guatemala
city: Hong Kong
country: Hong Kong
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Pachuca
country: Mexico
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Jud Covasna
country: Romania
city: Mures
country: Romania
city: Ploiesti
country: Romania
city: Satu Mare
country: Romania
city: Sibiu
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.