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.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: JTT-130; Drug: JTT-130 Placebo

• Study Type: Interventional
• Enrollment (Actual): 496
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czech Republic
  • Beroun, Czech Republic
  • Brno, Czech Republic
  • Ostrava, Czech Republic
  • Pardubice, Czech Republic
  • Prague, Czech Republic
  • Velke Hostice, Czech Republic
• Hungary
  • Satoraljaujhely, Hungary
  • Szikszo, Hungary
• Netherlands
  • Eindhoven, Netherlands
  • Groningen, Netherlands
• Russian Federation
  • Arkhangelsk, Russian Federation
  • Moscow, Russian Federation
  • Nizhniy Novgorod, Russian Federation
  • St. Petersburg, Russian Federation
• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Muscle Shoals, Alabama, United States
    • Scottsboro, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Encino, California, United States
    • Los Angeles, California, United States
    • Sacramento, California, United States
    • Spring Valley, California, United States
    • Valley Village, California, United States
    • Walnut Creek, California, United States
  • Connecticut
    • Waterbury, Connecticut, United States
  • Florida
    • Delray Beach, Florida, United States
    • Hialeah, Florida, United States
    • Miami, Florida, United States
    • New Port Richey, Florida, United States
    • Ocala, Florida, United States
  • Georgia
    • Sandy Springs, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Kentucky
    • Erlanger, Kentucky, United States
    • Lexington, Kentucky, United States
    • Louisville, Kentucky, United States
    • Madisonville, Kentucky, United States
    • Paducah, Kentucky, United States
  • New York
    • New Hyde Park, New York, United States
  • North Carolina
    • Greensboro, North Carolina, United States
    • Morehead City, North Carolina, United States
    • Statesville, North Carolina, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Marion, Ohio, United States
  • Oklahoma
    • Tulsa, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
    • Portland, Oregon, United States
  • South Carolina
    • Charleston, South Carolina, United States
    • Greer, South Carolina, United States
    • North Charleston, South Carolina, United States
  • Tennessee
    • Bristol, Tennessee, United States
  • Texas
    • Austin, Texas, United States
    • Corpus Christi, Texas, United States
    • Dallas, Texas, United States
    • Houston, Texas, United States
    • San Antonio, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Manassas, Virginia, United States
    • Richmond, Virginia, United States
  • Washington
    • Bellevue, Washington, United States
    • Olympia, Washington, United States
  • Wisconsin
    • Oregon, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: JTT-130 Placebo; Tablets
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in glycosylated hemoglobin (HbA1c) levels	End of Study

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability data	End of Study

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: June 26, 2009
• First Posted (Estimate): June 29, 2009

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: AT130-G-08-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No