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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00266253




Registration number
NCT00266253
Ethics application status
Date submitted
15/12/2005
Date registered
16/12/2005
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Scientific title
A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
Secondary ID [1] 0 0
BM18249
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 - GK Activator (2)
Treatment: Drugs - Metformin

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -

Experimental: 4 -

Experimental: 5 -

Active Comparator: 6 -


Treatment: Drugs: GK Activator (2)
Escalating doses, po bid or qd for 12 weeks.

Treatment: Drugs: Metformin
As prescribed, for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c mean change from baseline compared with placebo.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Additional parameters of glycemic and lipid control.
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
AEs, laboratory parameters.
Timepoint [2] 0 0
Throughout study
Secondary outcome [3] 0 0
Pharmacokinetic and exposure-response relationship
Timepoint [3] 0 0
Throughout study

Eligibility
Key inclusion criteria
- adult patients 30-75 years of age;

- type 2 diabetes mellitus;

- individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior
to screening.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- type 1 diabetes mellitus;

- any oral anti-hyperglycemic medication, other than metformin monotherapy, during last
3 months

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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment hospital [3] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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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
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
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United States of America
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Pennsylvania
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United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Germany
State/province [19] 0 0
Bammental
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Essen
Country [22] 0 0
Germany
State/province [22] 0 0
Giessen
Country [23] 0 0
Germany
State/province [23] 0 0
Görlitz
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Kuenzing
Country [26] 0 0
Germany
State/province [26] 0 0
Mannheim
Country [27] 0 0
Germany
State/province [27] 0 0
Nürnberg
Country [28] 0 0
Germany
State/province [28] 0 0
Tann
Country [29] 0 0
Spain
State/province [29] 0 0
Alzira
Country [30] 0 0
Spain
State/province [30] 0 0
Bacarot Alicant
Country [31] 0 0
Spain
State/province [31] 0 0
Baracaldo
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Dundee
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Frome
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Glasgow
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Liverpool
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Motherwell
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Northwood
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK
Activator (2) in combination with metformin, compared to that of placebo (metformin
monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their
stable dose of metformin and will be randomized to receive either GK Activator (2) or
placebo. The anticipated time on study treatment is less than 3 months, and the target sample
size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00266253
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00266253