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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00423501




Registration number
NCT00423501
Ethics application status
Date submitted
17/01/2007
Date registered
18/01/2007
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Scientific 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.
Secondary ID [1] 0 0
BC20688
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
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide
Treatment: Drugs - taspoglutide

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -

Experimental: 5 -

Placebo comparator: 6 -


Treatment: Drugs: Placebo
sc weekly

Treatment: Drugs: taspoglutide
20mg sc weekly

Treatment: Drugs: taspoglutide
10mg sc every 2 weeks

Treatment: Drugs: taspoglutide
5mg sc weekly

Treatment: Drugs: taspoglutide
10mg sc weekly

Treatment: Drugs: taspoglutide
20mg sc every 2 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change from baseline in HbAlc
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Changes in lipid profile
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
AEs, laboratory parameters, primary pharmacokinetic parameters
Timepoint [3] 0 0
Throughout study

Eligibility
Key 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.
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;
* 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.

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
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
306
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
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Dimitrovgrad
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Pleven
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Ruse
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Varna
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Lauterberg
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Görlitz
Country [16] 0 0
Germany
State/province [16] 0 0
Hannover
Country [17] 0 0
Germany
State/province [17] 0 0
Mainz
Country [18] 0 0
Germany
State/province [18] 0 0
Neuss
Country [19] 0 0
Germany
State/province [19] 0 0
Nürnberg
Country [20] 0 0
Guatemala
State/province [20] 0 0
Guatemala City
Country [21] 0 0
Hong Kong
State/province [21] 0 0
Hong Kong
Country [22] 0 0
Latvia
State/province [22] 0 0
Riga
Country [23] 0 0
Lithuania
State/province [23] 0 0
Kaunas
Country [24] 0 0
Lithuania
State/province [24] 0 0
Klaipeda
Country [25] 0 0
Lithuania
State/province [25] 0 0
Vilnius
Country [26] 0 0
Mexico
State/province [26] 0 0
Guadalajara
Country [27] 0 0
Mexico
State/province [27] 0 0
Mexico City
Country [28] 0 0
Mexico
State/province [28] 0 0
Monterrey
Country [29] 0 0
Mexico
State/province [29] 0 0
Pachuca
Country [30] 0 0
Romania
State/province [30] 0 0
Brasov
Country [31] 0 0
Romania
State/province [31] 0 0
Bucharest
Country [32] 0 0
Romania
State/province [32] 0 0
Cluj-napoca
Country [33] 0 0
Romania
State/province [33] 0 0
Jud Covasna
Country [34] 0 0
Romania
State/province [34] 0 0
Mures
Country [35] 0 0
Romania
State/province [35] 0 0
Ploiesti
Country [36] 0 0
Romania
State/province [36] 0 0
Satu Mare
Country [37] 0 0
Romania
State/province [37] 0 0
Sibiu

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00423501
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00423501