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

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: October 19, 2009
Last Update Posted: February 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akros Pharma Inc.
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) levels [ Time Frame: 3 months ]
  • Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters [ Time Frame: 3 months ]
  • Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events) [ Time Frame: 3 months ]

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
Experimental: Dose 2 JTT-654 Drug: JTT-654
Placebo Comparator: Placebo Drug: JTT-654 Placebo


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997152

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

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00997152     History of Changes
Other Study ID Numbers: AT654-U-09-004
First Submitted: October 14, 2009
First Posted: October 19, 2009
Last Update Posted: February 4, 2013
Last Verified: January 2013

Keywords provided by Akros Pharma Inc.:

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