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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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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
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
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Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
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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
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Germany
State/province [25] 0 0
Kuenzing
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Germany
State/province [26] 0 0
Mannheim
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Germany
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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
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United Kingdom
State/province [36] 0 0
Liverpool
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United Kingdom
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Motherwell
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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
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/NCT00266253