Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00460941




Registration number
NCT00460941
Ethics application status
Date submitted
16/04/2007
Date registered
17/04/2007
Date last updated
2/11/2016

Titles & IDs
Public title
A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Scientific 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.
Secondary ID [1] 0 0
BC20728
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Taspoglutide 20mg
Treatment: Drugs - Taspoglutide 20mg-30mg
Treatment: Drugs - Taspoglutide 20mg-40mg

Placebo comparator: Placebo - sc weekly

Experimental: Taspoglutide 20mg - sc weekly

Experimental: Taspoglutide 20mg-30mg - sc weekly

Experimental: Taspoglutide 20mg-40mg - sc weekly


Treatment: Drugs: Placebo
sc weekly

Treatment: Drugs: Taspoglutide 20mg
sc weekly

Treatment: Drugs: Taspoglutide 20mg-30mg
sc weekly

Treatment: Drugs: Taspoglutide 20mg-40mg
sc weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients withdrawn because of gastrointestinal effects
Timepoint [1] 0 0
Week 9
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 9

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
France
State/province [9] 0 0
Besancon
Country [10] 0 0
France
State/province [10] 0 0
Corbeil Essonnes
Country [11] 0 0
France
State/province [11] 0 0
Narbonne
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Poitiers
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
München
Country [16] 0 0
Germany
State/province [16] 0 0
Neuss
Country [17] 0 0
Mexico
State/province [17] 0 0
Chihuahua
Country [18] 0 0
Mexico
State/province [18] 0 0
Culiacan
Country [19] 0 0
Mexico
State/province [19] 0 0
Monterrey
Country [20] 0 0
Mexico
State/province [20] 0 0
Tampico
Country [21] 0 0
Peru
State/province [21] 0 0
Lima
Country [22] 0 0
Puerto Rico
State/province [22] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00460941