Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

Type II Diabetes Mellitus Clinical Trial

Official title:

A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929539
• Other study ID #: AT130-G-08-006
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: January 31, 2013
• Start date: June 2009
• Est. completion date: July 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 AdministrationUnited States: Institutional Review BoardCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteeHungary: National Institute of PharmacyRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: July 2010
• Est. primary completion date: May 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 > 27.0 kg/m2 and = 45.0 kg/m2;

3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding

2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;

3. Acute coronary syndrome or uncontrolled hypertension;

4. Does not meet medication restriction 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-130
Tablets
• JTT-130 Placebo
Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Countries where clinical trial is conducted

United States,  Czech Republic,  Hungary,  Netherlands,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycosylated hemoglobin (HbA1c) levels		End of Study	No
Secondary	Safety and tolerability data		End of Study	Yes