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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT00423501
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

Summary results
Other publications