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

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ClinicalTrials.gov Identifier: NCT00997152
Recruitment Status : Terminated
First Posted : October 19, 2009
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: JTT-654 Drug: JTT-654 Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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


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Sponsors and Collaborators
Akros Pharma Inc.

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

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