A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: GK Activator (2)
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 30-75 years of age; type 2 diabetes mellitus; individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening. Exclusion Criteria: type 1 diabetes mellitus; any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* Escalating doses, po bid or qd for 12 weeks.<br>Drug: Metformin<br>* As prescribed, for 12 weeks<br>|
| Experimental: 2<br> | Drug: GK Activator (2)<br>* Escalating doses, po bid or qd for 12 weeks.<br>Drug: Metformin<br>* As prescribed, for 12 weeks<br>|
| Experimental: 3<br> | Drug: GK Activator (2)<br>* Escalating doses, po bid or qd for 12 weeks.<br>Drug: Metformin<br>* As prescribed, for 12 weeks<br>|
| Experimental: 4<br> | Drug: GK Activator (2)<br>* Escalating doses, po bid or qd for 12 weeks.<br>Drug: Metformin<br>* As prescribed, for 12 weeks<br>|
| Experimental: 5<br> | Drug: GK Activator (2)<br>* Escalating doses, po bid or qd for 12 weeks.<br>Drug: Metformin<br>* As prescribed, for 12 weeks<br>|
| Active Comparator: 6<br> | Drug: Metformin<br>* As prescribed, for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c mean change from baseline compared with placebo. |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional parameters of glycemic and lipid control. |  | Week 12 | 
| AEs, laboratory parameters. |  | Throughout study | 
| Pharmacokinetic and exposure-response relationship |  | Throughout study |