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A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Glenmark Pharmaceuticals Europe Ltd. (R&D).
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
ClinicalTrials.gov Identifier:
NCT00836940
First received: February 3, 2009
Last updated: September 23, 2009
Last verified: September 2009
February 3, 2009
September 23, 2009
June 2008
May 2009   (Final data collection date for primary outcome measure)
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00836940 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
  • Placebo Comparator: 1
    Intervention: Drug: GRC 8200
  • Experimental: 2
    GRC 8200-25mg OD
    Intervention: Drug: GRC 8200
  • Experimental: 3
    GRC 8200-50mg OD
    Intervention: Drug: GRC 8200
  • Experimental: 4
    GRC 8200-50mg BD
    Intervention: Drug: GRC 8200
  • Experimental: 5
    GRC 8200-100mg OD
    Intervention: Drug: GRC 8200
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
480
October 2009
May 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00836940
GRC 8200-301
Yes
Not Provided
Not Provided
Not Provided
Dr Manmath Patekar, Glenmark Pharmaceuticals ltd
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Not Provided
Not Provided
Glenmark Pharmaceuticals Europe Ltd. (R&D)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP