Efficacy and Safety of TAK-379 in Adult Subjects With Type 2 Diabetes Mellitus

Phase 2

Terminated

• Conditions: Diabetes Mellitus
• Interventions: Drug: TAK-379; Drug: Placebo; Drug: Pioglitazone

• Registration Number: NCT00722917
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of multiple doses of TAK-379, once daily (QD), in subjects with type 2 diabetes mellitus.

Detailed Description

Type 2 diabetes is a metabolic disease that has reached epidemic proportions. The global incidence of this disease is estimated to increase from 120 million individuals to over 200 million by the year 2010. In type 2 diabetes, multiple metabolic defects contribute to hyperglycemia. These include insulin resistance, inadequate insulin secretion, and excessive hepatic glucose production. Nine classes of antihyperglycemic agents are currently approved for the treatment of type 2 diabetes (insulin, sulfonylureas, biguanides, alpha-glycosidase inhibitors, thiazolidinediones, glinides, glucagon-like peptide analogues, amylin analogues, and dipeptidyl peptidase 4 inhibitors). Each class acts by a unique mechanism on 1 or more of the metabolic defects.

Takeda Pharmaceutical Company Limited is developing TAK-379, a non-thiazolidinedione partial proliferator-activated receptor agonist for the treatment of type 2 diabetes mellitus. Study participation is anticipated to be approximately 4.5 months.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2016-06
• Disposition First Submitted: 2016-06-20
• Disposition First Submitted QC: 2016-06-20
• Last Update Submitted: 2016-06-20
• Disposition First Posted: 2016-06-22
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-379 200 mg QD	TAK-379	-
Placebo	Placebo	-
TAK-379 25 mg QD	TAK-379	-
TAK-379 100 mg QD	TAK-379	-
Pioglitazone 30 mg QD	Pioglitazone	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Glycosylated Hemoglobin	Week 12 or Final Visit

Secondary Outcome Measures

Name	Time	Method
Number of patients with elevation of alanine aminotransferase greater than three times the Upper Limit of Normal during treatment.	Week 12 or Final Visit
Change from baseline in glycosylated hemoglobin.	Weeks 4 and 8 or Final Visit
Change from baseline in fasting plasma glucose.	Weeks 1, 2, 4, 8 and 12 or Final Visit
Change from baseline in body weight.	Weeks 4, 8 and 12 or Final Visit
Plasma concentrations of TAK-379 and its metabolite M-I via a sparse sampling population approach.	Week 12 or Final Visit