Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00929539
First received: June 26, 2009
Last updated: January 31, 2013
Last verified: January 2013

June 26, 2009
January 31, 2013
June 2009
May 2010   (final data collection date for primary outcome measure)
Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929539 on ClinicalTrials.gov Archive Site
Safety and tolerability data [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients

The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: JTT-130
    Tablets
  • Drug: JTT-130 Placebo
    Tablets
  • Experimental: Dose 1 JTT-130
    Intervention: Drug: JTT-130
  • Experimental: Dose 2 JTT-130
    Intervention: Drug: JTT-130
  • Experimental: Dose 3 JTT-130
    Intervention: Drug: JTT-130
  • Placebo Comparator: Placebo
    Intervention: Drug: JTT-130 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
496
July 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have type 2 diabetes;
  2. Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;
  3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria:

  1. Females who are pregnant or breast-feeding
  2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
  3. Acute coronary syndrome or uncontrolled hypertension;
  4. Does not meet medication restriction criteria, as described in the protocol.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Russian Federation,   Czech Republic,   Hungary,   Netherlands
 
NCT00929539
AT130-G-08-006
No
Akros Pharma Inc.
Akros Pharma Inc.
Not Provided
Not Provided
Akros Pharma Inc.
January 2013

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