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

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Sponsors

Lead sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date February 2006
Completion Date October 2007
Primary Completion Date October 2007
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
AEs, laboratory parameters, ECG. Throughout study
Secondary Outcome
Measure Time Frame
Mean change from original baseline in HbA1c, FPG, lipid profile. Throughout study
Enrollment 259
Condition
Intervention

Intervention type: Drug

Intervention name: GK Activator (2)

Description: Escalating doses bid

Arm group label: 1

Intervention type: Drug

Intervention name: Metformin

Description: As prescribed, in patients who were in study BM18249

Arm group label: 1

Eligibility

Criteria:

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).

Exclusion Criteria:

- type 1 diabetes mellitus;

- women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Gender: All

Minimum age: 30 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
facility
| Chula Vista, California, 91910, United States
| Chula Vista, California, 91911, United States
| Los Angeles, California, 90057, United States
| Spring Valley, California, 91978, United States
| West Hills, California, 91307, United States
| Hollywood, Florida, 33021, United States
| Kissimmee, Florida, 34741, United States
| Atlanta, Georgia, 30308, United States
| Arkansas City, Kansas, 67005, United States
| Butte, Montana, 59701, United States
| Binghamton, New York, 13901, United States
| Fayetteville, North Carolina, 28304, United States
| Statesville, North Carolina, 28625, United States
| Winston-salem, North Carolina, 27103, United States
| Springdale, Ohio, 45246, United States
| Oklahoma City, Oklahoma, 73112, United States
| Medford, Oregon, 97504, United States
| Beaver, Pennsylvania, 15009, United States
| Mount Pleasant, South Carolina, 29464, United States
| Memphis, Tennessee, 38119, United States
| Federal Way, Washington, 98003, United States
| Renton, Washington, 98055, United States
| Camperdown, 2050, Australia
| Heidelberg, 3081, Australia
| Dimitrovgrad, 6400, Bulgaria
| Pleven, 5800, Bulgaria
| Ruse, 7002, Bulgaria
| Sofia, 1233, Bulgaria
| Sofia, 1606, Bulgaria
| Vancouver, British Columbia, V5Z 1M9, Canada
| London, Ontario, NGA 4V2, Canada
| Montreal, Quebec, H1T 2M4, Canada
| Zagreb, 10000, Croatia
| Bammental, 69245, Germany
| Berlin, 10115, Germany
| Essen, 45355, Germany
| Giessen, 35385, Germany
| Görlitz, 02826, Germany
| Hamburg, 20249, Germany
| Kuenzing, 94550, Germany
| Nürnberg, 90402, Germany
| Tann, 36142, Germany
| Guatemala City, 01015, Guatemala
| Budapest, 1083, Hungary
| Gyor, 9024, Hungary
| Kecskemet, 6000, Hungary
| Chihuahua, 31238, Mexico
| Cuernavaca, 62270, Mexico
| Durango, 34070, Mexico
| Mexico City, 11650, Mexico
| Mexico City, 14050, Mexico
| Mexico City, 14610, Mexico
| Mexico-city, 06700, Mexico
| Bialystok, 15-276, Poland
| Gdansk, 80-757, Poland
| Gorzow, 66-400, Poland
| Krakow, 31-121, Poland
| Wroclaw, 50-088, Poland
Location Countries

Australia

Bulgaria

Canada

Croatia

Germany

Guatemala

Hungary

Mexico

Poland

United States

Verification Date

November 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: 1

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov