Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: JTT-851
* Drug: Glimepiride
* Drug: Placebo for Active
* Drug: Placebo for comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JTT-851 Dose 1<br>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks | Drug: JTT-851<br> <br> Drug: Placebo for comparator<br> <br> |
| Experimental: JTT-851 Dose 2<br>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks | Drug: JTT-851<br> <br> Drug: Placebo for comparator<br> <br> |
| Experimental: JTT-851 Dose 3<br>JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks | Drug: JTT-851<br> <br> Drug: Placebo for comparator<br> <br> |
| Active Comparator: Glimepiride Dose 1<br>Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks | Drug: Glimepiride<br>* Encapsulated Glimepiride tablets<br>Drug: Placebo for Active<br> <br> |
| Placebo Comparator: Placebo active & Placebo comparator<br>Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks | Drug: Placebo for Active<br> <br> Drug: Placebo for comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851 | To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo | 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. | 12 weeks | 
| Effect on ancillary efficacy measures | To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo. | 12 weeks | 
| Pharmacokinetics of JTT-851 and its metabolites | To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes