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

Primary Purpose

Type II Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JTT-130
JTT-130 Placebo
Sponsored by
Akros Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1 JTT-130

Dose 2 JTT-130

Dose 3 JTT-130

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in glycosylated hemoglobin (HbA1c) levels

Secondary Outcome Measures

Safety and tolerability data

Full Information

First Posted
June 26, 2009
Last Updated
January 31, 2013
Sponsor
Akros Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00929539
Brief Title
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus
Keywords
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 JTT-130
Arm Type
Experimental
Arm Title
Dose 2 JTT-130
Arm Type
Experimental
Arm Title
Dose 3 JTT-130
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JTT-130
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
JTT-130 Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Change in glycosylated hemoglobin (HbA1c) levels
Time Frame
End of Study
Secondary Outcome Measure Information:
Title
Safety and tolerability data
Time Frame
End of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have type 2 diabetes; Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2; 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: Females who are pregnant or breast-feeding Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy; Acute coronary syndrome or uncontrolled hypertension; Does not meet medication restriction criteria, as described in the protocol.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Muscle Shoals
State/Province
Alabama
Country
United States
City
Scottsboro
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Encino
State/Province
California
Country
United States
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Los Angeles
State/Province
California
Country
United States
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Sacramento
State/Province
California
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United States
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Spring Valley
State/Province
California
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United States
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Valley Village
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California
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United States
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Walnut Creek
State/Province
California
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United States
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Waterbury
State/Province
Connecticut
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United States
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Delray Beach
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Florida
Country
United States
City
Hialeah
State/Province
Florida
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United States
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Miami
State/Province
Florida
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United States
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New Port Richey
State/Province
Florida
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United States
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Ocala
State/Province
Florida
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United States
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Sandy Springs
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Georgia
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United States
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Chicago
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Illinois
Country
United States
City
Indianapolis
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Indiana
Country
United States
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Erlanger
State/Province
Kentucky
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
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Louisville
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Kentucky
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United States
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Madisonville
State/Province
Kentucky
Country
United States
City
Paducah
State/Province
Kentucky
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Morehead City
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Marion
State/Province
Ohio
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United States
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Tulsa
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Oklahoma
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United States
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Eugene
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Oregon
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United States
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Portland
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Oregon
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United States
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Charleston
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South Carolina
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United States
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Greer
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South Carolina
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United States
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North Charleston
State/Province
South Carolina
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United States
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Bristol
State/Province
Tennessee
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United States
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Austin
State/Province
Texas
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United States
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Corpus Christi
State/Province
Texas
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United States
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Dallas
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Texas
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United States
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Houston
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Texas
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United States
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San Antonio
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Texas
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United States
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Salt Lake City
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Utah
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United States
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Manassas
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Virginia
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United States
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Richmond
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Virginia
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United States
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Bellevue
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Washington
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United States
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Olympia
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Washington
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United States
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Oregon
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Wisconsin
Country
United States
City
Beroun
Country
Czech Republic
City
Brno
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Pardubice
Country
Czech Republic
City
Prague
Country
Czech Republic
City
Velke Hostice
Country
Czech Republic
City
Satoraljaujhely
Country
Hungary
City
Szikszo
Country
Hungary
City
Eindhoven
Country
Netherlands
City
Groningen
Country
Netherlands
City
Arkhangelsk
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhniy Novgorod
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation

12. IPD Sharing Statement

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

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