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

Phase 2

Terminated

• Conditions: Type II Diabetes Mellitus
• Interventions: Drug: JTT-654; Drug: JTT-654 Placebo

• Registration Number: NCT00997152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-31
• Disposition First Submitted QC: 2013-01-31
• Last Update Submitted: 2013-01-31
• Disposition First Posted: 2013-02-04
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 JTT-654	JTT-654	-
Dose 2 JTT-654	JTT-654	-
Placebo	JTT-654 Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG) levels	3 months

Secondary Outcome Measures

Name	Time	Method
Change in glycosylated hemoglobin (HbA1c) levels	3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters	3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)	3 months