Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997152

Enrollment

152

Registered

2009-10-19

Start date

2009-09-30

Completion date

2010-04-30

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-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.

Interventions

DRUGJTT-654

Tablets

DRUGJTT-654 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 ≤ 45.0 kg/m2; 3. Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.

Exclusion criteria

1. Females who are pregnant or breast-feeding; 2. Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy; 3. Acute coronary syndrome or uncontrolled hypertension; 4. Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.

Design outcomes

Primary

Measure	Time frame
Change in Fasting Plasma Glucose (FPG) levels	3 months

Secondary

Measure	Time frame
Change in glycosylated hemoglobin (HbA1c) levels	3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters	3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)	3 months

Countries

United States

Outcome results

None listed

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