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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01699737

Enrollment

325

Registered

2012-10-04

Start date

2012-09-30

Completion date

2013-07-31

Last updated

2013-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes

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.

Interventions

DRUGJTT-851

DRUGGlimepiride

Encapsulated Glimepiride tablets

DRUGPlacebo for Active

DRUGPlacebo for comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Relationship between dose and response of JTT-851	12 weeks	To explore the relationship between the JTT-851 dose (exposure) and response

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026