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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 14, 2009
Last Updated Date	January 31, 2013
Start Date ^ICMJE	September 2009
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2009)	Change in Fasting Plasma Glucose (FPG) levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00997152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 16, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Type II Diabetes Mellitus
Intervention ^ICMJE	Drug: JTT-654 Tablets Drug: JTT-654 Placebo Tablets
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	152
Completion Date	April 2010
Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00997152
Other Study ID Numbers ^ICMJE	AT654-U-09-004
Has Data Monitoring Committee	No
Responsible Party	Akros Pharma Inc.
Study Sponsor ^ICMJE	Akros Pharma Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Akros Pharma Inc.
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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