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

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Type II Diabetes Mellitus

Treatments: Drug: JTT-130 Placebo; Drug: JTT-130

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929539

AT130-G-08-006

Details and patient eligibility

About

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.

Enrollment: 496 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

496 participants in 4 patient groups, including a placebo group

Dose 1 JTT-130

Experimental group

Treatment:

Drug: JTT-130

Dose 2 JTT-130

Experimental group

Treatment:

Drug: JTT-130

Dose 3 JTT-130

Experimental group

Treatment:

Drug: JTT-130

Placebo

Placebo Comparator group

Treatment:

Drug: JTT-130 Placebo