Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01699737
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.
- Detailed Description
This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- Males and females with type 2 diabetes, 18-70 years of age at Visit 1
- Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
- Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
- Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1
- Females who are pregnant or breast-feeding
- Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
- Acute coronary syndrome or uncontrolled hypertension
- Does not meet all diet or previous/concomitant medication restriction criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JTT-851 Dose 1 Placebo for comparator JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks JTT-851 Dose 2 Placebo for comparator JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks JTT-851 Dose 3 JTT-851 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks JTT-851 Dose 3 Placebo for comparator JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks Glimepiride Dose 1 Placebo for Active Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks Placebo active & Placebo comparator Placebo for Active Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks Placebo active & Placebo comparator Placebo for comparator Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks JTT-851 Dose 1 JTT-851 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks JTT-851 Dose 2 JTT-851 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks Glimepiride Dose 1 Glimepiride Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851 12 weeks To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo 12 weeks To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.
Effect on ancillary efficacy measures 12 weeks To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.
Pharmacokinetics of JTT-851 and its metabolites 12 weeks To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes