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.
1 other identifier
interventional
133
7 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Apr 2007
Shorter than P25 for phase_2 diabetes-mellitus-type-2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 16, 2007
CompletedFirst Posted
Study publicly available on registry
April 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedNovember 2, 2016
November 1, 2016
9 months
April 16, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients withdrawn because of gastrointestinal effects
Week 9
Secondary Outcomes (1)
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
Study Arms (4)
Placebo
PLACEBO COMPARATORsc weekly
Taspoglutide 20mg
EXPERIMENTALsc weekly
Taspoglutide 20mg-30mg
EXPERIMENTALsc weekly
Taspoglutide 20mg-40mg
EXPERIMENTALsc weekly
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Harrisburg, Arkansas, 72432, United States
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Hyattsville, Maryland, 20783, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Adelaide, 5000, Australia
Unknown Facility
Camperdown, 2050, Australia
Unknown Facility
Besançon, 25030, France
Unknown Facility
Corbeil-Essonnes, 91106, France
Unknown Facility
Narbonne, 11108, France
Unknown Facility
Paris, 75877, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Berlin, 10115, Germany
Unknown Facility
München, 80636, Germany
Unknown Facility
Neuss, 41460, Germany
Unknown Facility
Chihuahua City, 31238, Mexico
Unknown Facility
Culiacán, 80020, Mexico
Unknown Facility
Monterrey, 64410, Mexico
Unknown Facility
Tampico, 89109, Mexico
Unknown Facility
Lima, 10, Peru
Unknown Facility
Lima, 31, Peru
Unknown Facility
Lima, LIMA 29, Peru
Unknown Facility
Ponce, 00716, Puerto Rico
Related Publications (1)
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.
PMID: 20536952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2007
First Posted
April 17, 2007
Study Start
April 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
November 2, 2016
Record last verified: 2016-11