Long-term Study of KAD-1229 in Type 2 Diabetes Patients

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: KAD-1229

• Registration Number: NCT01333592
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-10
• Study First Posted: 2011-04-12
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2014-11
• Results First Submitted: 2014-11-17
• Results First Submitted QC: 2014-11-17
• Results First Posted: 2014-11-24
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
• Age in the 20 years or over inclusive
• HbA1c in the range of ≥ 6.5 to < 9%

Exclusion Criteria

• Type 1 diabetes mellitus
• Patients with serious diabetic complications and other serious complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KAD-1229	KAD-1229	-

Primary Outcome Measures

Name	Time	Method
Incidences of Adverse Events	52 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at 52 Weeks	at week 0 and week 52

Trial Locations

Locations (1)

Japan; 🇯🇵 Kanto region, Chugoku region, Kyushu region, Japan