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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929539
First Posted: June 29, 2009
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akros Pharma Inc.
June 26, 2009
June 29, 2009
February 4, 2013
June 2009
May 2010   (Final data collection date for primary outcome measure)
Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: End of Study ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary,   Netherlands,   Russian Federation,   United States
 
 
NCT00929539
AT130-G-08-006
No
Not Provided
Not Provided
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