Back to resultsEfficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
Primary Purpose
Type II Diabetes Mellitus
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JTT-654
JTT-654 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Diabetes
Eligibility Criteria
Inclusion Criteria:
- Have type 2 diabetes;
- Body mass index (BMI) of ≤ 45.0 kg/m2;
- Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Exclusion Criteria:
- Females who are pregnant or breast-feeding;
- Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dose 1 JTT-654
Dose 2 JTT-654
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Fasting Plasma Glucose (FPG) levels
Secondary Outcome Measures
Change in glycosylated hemoglobin (HbA1c) levels
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00997152
Brief Title
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
Official Title
A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 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-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in 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
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 JTT-654
Arm Type
Experimental
Arm Title
Dose 2 JTT-654
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JTT-654
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
JTT-654 Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose (FPG) levels
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in glycosylated hemoglobin (HbA1c) levels
Time Frame
3 months
Title
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
Time Frame
3 months
Title
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
Time Frame
3 months
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 ≤ 45.0 kg/m2;
Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Exclusion Criteria:
Females who are pregnant or breast-feeding;
Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
Acute coronary syndrome or uncontrolled hypertension;
Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Chandler
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tempe
State/Province
Arizona
Country
United States
City
Chino
State/Province
California
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
Huntington Park
State/Province
California
Country
United States
City
Los Angeles
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California
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United States
City
Paramount
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California
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United States
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Sacramento
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California
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United States
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Walnut Creek
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California
Country
United States
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West Covina
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California
Country
United States
City
Deland
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Florida
Country
United States
City
Hialeah
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Florida
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United States
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Hollywood
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Florida
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United States
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Jacksonville
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Florida
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United States
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Miami
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United States
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Port Orange
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United States
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Marietta
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Georgia
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United States
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Addison
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Illinois
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United States
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Chicago
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Illinois
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United States
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Indianapolis
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Indiana
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United States
City
Oxon Hill
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Maryland
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United States
City
New Bedford
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Massachusetts
Country
United States
City
Great Falls
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Montana
Country
United States
City
Charlotte
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North Carolina
Country
United States
City
Morehead City
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North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Marion
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Ohio
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United States
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Oklahoma City
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Oklahoma
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United States
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Lansdale
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Pennsylvania
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United States
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Bristol
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Tennessee
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United States
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Carrollton
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Texas
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United States
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Corpus Christi
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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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Katy
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Texas
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United States
City
San Antonio
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Texas
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United States
City
Sugar Land
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Virginia Beach
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
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Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
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