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

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

Further study details as provided by Akros Pharma Inc.:

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

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

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
Experimental: Dose 2 JTT-130 Drug: JTT-130
Experimental: Dose 3 JTT-130 Drug: JTT-130
Placebo Comparator: Placebo Drug: JTT-130 Placebo


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00929539

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United States, Alabama
Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Scottsboro, Alabama, United States
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Tucson, Arizona, United States
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Encino, California, United States
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Arkhangelsk, Russian Federation
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St. Petersburg, Russian Federation
Sponsors and Collaborators
Akros Pharma Inc.
  More Information

Responsible Party: Akros Pharma Inc. Identifier: NCT00929539     History of Changes
Other Study ID Numbers: AT130-G-08-006
Study First Received: June 26, 2009
Last Updated: January 31, 2013

Keywords provided by Akros Pharma Inc.:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 22, 2017