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

Diabetes Mellitus Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316758
• Other study ID #: NC19794
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2006
• Last updated: November 1, 2016
• Start date: February 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GK Activator (2)
Escalating doses bid
• Metformin
As prescribed, in patients who were in study BM18249

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Croatia,  Germany,  Guatemala,  Hungary,  Mexico,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs, laboratory parameters, ECG.		Throughout study	No
Secondary	Mean change from original baseline in HbA1c, FPG, lipid profile.		Throughout study	No