Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00997152
First received: October 14, 2009
Last updated: January 31, 2013
Last verified: January 2013

October 14, 2009
January 31, 2013
September 2009
March 2010   (final data collection date for primary outcome measure)
Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997152 on ClinicalTrials.gov Archive Site
  • Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: JTT-654
    Tablets
  • Drug: JTT-654 Placebo
    Tablets
  • Experimental: Dose 1 JTT-654
    Intervention: Drug: JTT-654
  • Experimental: Dose 2 JTT-654
    Intervention: Drug: JTT-654
  • Placebo Comparator: Placebo
    Intervention: Drug: JTT-654 Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
152
April 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have type 2 diabetes;
  2. Body mass index (BMI) of ≤ 45.0 kg/m2;
  3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion Criteria:

  1. Females who are pregnant or breast-feeding;
  2. 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;
  3. Acute coronary syndrome or uncontrolled hypertension;
  4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00997152
AT654-U-09-004
No
Akros Pharma Inc.
Akros Pharma Inc.
Not Provided
Not Provided
Akros Pharma Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP