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A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

NCT00836940 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2009-09-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

GRC 8200

Capsules, 25 to 100mg, once/ twice a day, 12 weeks

Sponsors & Collaborators

  • Glenmark Pharmaceuticals Europe Ltd. (R&D)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-05-31
Completion
2009-10-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836940 on ClinicalTrials.gov