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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
 Drug: JTT-130
Drug: JTT-130 Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability data [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Enrollment: 496
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 JTT-130 Drug: JTT-130
Tablets
Experimental: Dose 2 JTT-130 Drug: JTT-130
Tablets
Experimental: Dose 3 JTT-130 Drug: JTT-130
Tablets
Placebo Comparator: Placebo Drug: JTT-130 Placebo
Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929539

  Show 62 Study Locations
Sponsors and Collaborators
Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00929539     History of Changes
Other Study ID Numbers: AT130-G-08-006
Study First Received: June 26, 2009
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Akros Pharma Inc.:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013