Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment grc 8200
Phase phase 2
Sponsor Glenmark Pharmaceuticals Europe Ltd. (R&D)
Start date June 2008
End date May 2009
Trial size 480 participants
Trial identifier NCT00836940, GRC 8200-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
grc 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
(Experimental)
GRC 8200-25mg OD
grc 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
(Experimental)
GRC 8200-50mg OD
grc 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
(Experimental)
GRC 8200-50mg BD
grc 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
(Experimental)
GRC 8200-100mg OD
grc 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks

Primary Outcomes

Measure
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
time frame: 12 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Glenmark Pharmaceuticals Europe Ltd. (R&D).