Clinical trial NCT00460941: A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 133
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients withdrawn because of gastrointestinal effects
timeFrame: Week 9
Secondary outcomes:
measure: 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.
timeFrame: Week 9
Other outcomes:
Locations:
city: Harrisburg
country: United States
state: Arkansas
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: National City
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Madisonville
country: United States
state: Kentucky
city: Hyattsville
country: United States
state: Maryland
city: Winston-salem
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Adelaide
country: Australia
city: Camperdown
country: Australia
city: Besancon
country: France
city: Corbeil Essonnes
country: France
city: Narbonne
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Berlin
country: Germany
city: München
country: Germany
city: Neuss
country: Germany
city: Chihuahua
country: Mexico
city: Culiacan
country: Mexico
city: Monterrey
country: Mexico
city: Tampico
country: Mexico
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Ponce
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x.