Back to resultsA Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Taspoglutide 20mg
Taspoglutide 20mg-30mg
Taspoglutide 20mg-40mg
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Taspoglutide 20mg
Taspoglutide 20mg-30mg
Taspoglutide 20mg-40mg
Arm Description
sc weekly
sc weekly
sc weekly
sc weekly
Outcomes
Primary Outcome Measures
Percentage of patients withdrawn because of gastrointestinal effects
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00460941
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sc weekly
Arm Title
Taspoglutide 20mg
Arm Type
Experimental
Arm Description
sc weekly
Arm Title
Taspoglutide 20mg-30mg
Arm Type
Experimental
Arm Description
sc weekly
Arm Title
Taspoglutide 20mg-40mg
Arm Type
Experimental
Arm Description
sc weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sc weekly
Intervention Type
Drug
Intervention Name(s)
Taspoglutide 20mg
Intervention Description
sc weekly
Intervention Type
Drug
Intervention Name(s)
Taspoglutide 20mg-30mg
Intervention Description
sc weekly
Intervention Type
Drug
Intervention Name(s)
Taspoglutide 20mg-40mg
Intervention Description
sc weekly
Primary Outcome Measure Information:
Title
Percentage of patients withdrawn because of gastrointestinal effects
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
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.
Time Frame
Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20783
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
City
Narbonne
ZIP/Postal Code
11108
Country
France
City
Paris
ZIP/Postal Code
75877
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Berlin
ZIP/Postal Code
10115
Country
Germany
City
München
ZIP/Postal Code
80636
Country
Germany
City
Neuss
ZIP/Postal Code
41460
Country
Germany
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
City
Monterrey
ZIP/Postal Code
64410
Country
Mexico
City
Tampico
ZIP/Postal Code
89109
Country
Mexico
City
Lima
ZIP/Postal Code
10
Country
Peru
City
Lima
ZIP/Postal Code
31
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20536952
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. Erratum In: Diabet Med. 2010 Jun;27(6):732.
Results Reference
derived
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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.
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