A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients. The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients. This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.

Official Title
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A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: GRC 8200


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients ≥30 years of age At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs Has an HbA1c value at screening between 6.5% and 10% Exclusion Criteria: Has type 1 diabetes Is a female who is lactating or is pregnant Has a history of acute metabolic diabetic complications Has clinically significant disease other than type 2 diabetes mellitus

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 2<br>GRC 8200-25mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 3<br>GRC 8200-50mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 4<br>GRC 8200-50mg BD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|
| Experimental: 5<br>GRC 8200-100mg OD | Drug: GRC 8200<br>* Capsules, 25 to 100mg, once/ twice a day, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment |  | 4 and 8 weeks | 
| Fasting plasma glucose and fasting serum insulin |  | 12 weeks | 
| Plasma glucose 2 hours post glucose challenge (OGTT) |  | 12 weeks | 
| HOMA-IR |  | 12 weeks | 
| HOMA-B |  | 12 weeks | 
| Change in serum lipids |  | 12 weeks | 
| Body weight |  | 12 weeks | 
| Waist circumference |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, GRC 8200