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

Type 2 Diabetes Clinical Trial

Official title:

A Multicenter, Open Label, Long-term Study of KAD-1229 in Type 2 Diabetes Patients Who Show Inadequate Glycemic Control With Diet, and Biguanide or DPP-4 Inhibitor Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333592
• Other study ID #: KAD4301
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2011
• Last updated: November 27, 2014
• Est. completion date: November 2012

Study information

• Verified date: November 2014
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• KAD-1229

Locations

Country	Name	City	State
Japan	Japan	Kanto region, Chugoku region, Kyushu region

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of Adverse Events		52 weeks	Yes
Secondary	Change From Baseline in HbA1c at 52 Weeks		at week 0 and week 52	No