A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: GK Activator (2); Drug: Placebo

• Registration Number: NCT00266240
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Study First Posted: 2005-12-16
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• adult patients 30-75 years of age;
• type 2 diabetes mellitus for >3 months before screening;
• treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

Exclusion Criteria

• type 1 diabetes mellitus;
• women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	GK Activator (2)	-
2	GK Activator (2)	-
1	GK Activator (2)	-
4	GK Activator (2)	-
5	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c mean change from baseline, compared to placebo.	Week 12

Secondary Outcome Measures

Name	Time	Method
Additional parameters of glycemic and lipid control.	Week 12
AEs, laboratory parameters.	Throughout study
Pharmacokinetic and exposure-response relationship	Throughout study