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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316758

Enrollment

259

Registered

2006-04-21

Start date

2006-02-28

Completion date

2007-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGGK Activator (2)

Escalating doses bid

DRUGMetformin

As prescribed, in patients who were in study BM18249

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
AEs, laboratory parameters, ECG.	Throughout study

Secondary

Measure	Time frame
Mean change from original baseline in HbA1c, FPG, lipid profile.	Throughout study

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026