Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00316758




Registration number
NCT00316758
Ethics application status
Date submitted
20/04/2006
Date registered
21/04/2006
Date last updated
2/11/2016

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.
Scientific title
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249
Secondary ID [1] 0 0
NC19794
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 -


Treatment: Drugs: GK Activator (2)
Escalating doses bid

Treatment: Drugs: Metformin
As prescribed, in patients who were in study BM18249
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AEs, laboratory parameters, ECG.
Timepoint [1] 0 0
Throughout study
Secondary outcome [1] 0 0
Mean change from original baseline in HbA1c, FPG, lipid profile.
Timepoint [1] 0 0
Throughout study

Eligibility
Key inclusion criteria
* type 2 diabetic patients who have completed studies BM18248 or BM18249;
* patients considered by the investigator to be suitable for long term treatment with GK Activator (2).
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;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2007
Sample size
Target
Accrual to date
Final
259
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Montana
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
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
Bulgaria
State/province [15] 0 0
Dimitrovgrad
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pleven
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Ruse
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Germany
State/province [23] 0 0
Bammental
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Giessen
Country [27] 0 0
Germany
State/province [27] 0 0
Görlitz
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Kuenzing
Country [30] 0 0
Germany
State/province [30] 0 0
Nürnberg
Country [31] 0 0
Germany
State/province [31] 0 0
Tann
Country [32] 0 0
Guatemala
State/province [32] 0 0
Guatemala City
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Gyor
Country [35] 0 0
Hungary
State/province [35] 0 0
Kecskemet
Country [36] 0 0
Mexico
State/province [36] 0 0
Chihuahua
Country [37] 0 0
Mexico
State/province [37] 0 0
Cuernavaca
Country [38] 0 0
Mexico
State/province [38] 0 0
Durango
Country [39] 0 0
Mexico
State/province [39] 0 0
Mexico City
Country [40] 0 0
Mexico
State/province [40] 0 0
Mexico-city
Country [41] 0 0
Poland
State/province [41] 0 0
Bialystok
Country [42] 0 0
Poland
State/province [42] 0 0
Gdansk
Country [43] 0 0
Poland
State/province [43] 0 0
Gorzow
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw

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 long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/study/NCT00316758
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/study/NCT00316758