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

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.
ClinicalTrials.gov Identifier: NCT00929539
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: JTT-130 Drug: JTT-130 Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2009
Primary Completion Date : May 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: End of Study ]

Secondary Outcome Measures :
  1. Safety and tolerability data [ Time Frame: End of Study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929539


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

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00929539     History of Changes
Other Study ID Numbers: AT130-G-08-006
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: January 2013

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