A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Glenmark Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: GRC 8200

Study type: Interventional

Funder types: Industry

Identifiers

NCT00836940

GRC 8200-301

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 5 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: GRC 8200

2

Experimental group

Description:

GRC 8200-25mg OD

Treatment:

Drug: GRC 8200

3

Experimental group

Description:

GRC 8200-50mg OD

Treatment:

Drug: GRC 8200

4

Experimental group

Description:

GRC 8200-50mg BD

Treatment:

Drug: GRC 8200

5

Experimental group

Description:

GRC 8200-100mg OD

Treatment:

Drug: GRC 8200