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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014