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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929539

Enrollment

496

Registered

2009-06-29

Start date

2009-06-30

Completion date

2010-07-31

Last updated

2013-02-04

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

Conditions

Type II Diabetes Mellitus

Keywords

Diabetes

Brief 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.

Interventions

DRUGJTT-130

Tablets

DRUGJTT-130 Placebo

Tablets

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

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.

Design outcomes

Primary

Measure	Time frame
Change in glycosylated hemoglobin (HbA1c) levels	End of Study

Secondary

Measure	Time frame
Safety and tolerability data	End of Study

Countries

Czechia, Hungary, Netherlands, Russia, United States

Outcome results

None listed

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