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

Kissei

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: KAD-1229

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333592

KAD4301

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

KAD-1229

Experimental group

Treatment:

Drug: KAD-1229