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
  Purpose

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.


Condition Intervention Phase
Type II Diabetes Mellitus
Drug: JTT-654
Drug: JTT-654 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 152
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 JTT-654 Drug: JTT-654
Tablets
Experimental: Dose 2 JTT-654 Drug: JTT-654
Tablets
Placebo Comparator: Placebo Drug: JTT-654 Placebo
Tablets

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997152

  Show 42 Study Locations
Sponsors and Collaborators
Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00997152     History of Changes
Other Study ID Numbers: AT654-U-09-004
Study First Received: October 14, 2009
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Akros Pharma Inc.:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014