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

Type II Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00997152
• Other study ID #: AT654-U-09-004
• Status: Terminated
• Phase: Phase 2
• First received: October 14, 2009
• Last updated: January 31, 2013
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2013
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Drug:
• JTT-654
Tablets
• JTT-654 Placebo
Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fasting Plasma Glucose (FPG) levels		3 months	No
Secondary	Change in glycosylated hemoglobin (HbA1c) levels		3 months	No
Secondary	Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters		3 months	No
Secondary	Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)		3 months	Yes