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

Kissei Pharmaceutical Co., Ltd.136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Type 2 Diabetes

Interventions

KAD-1229DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Japan

Kanto Region, Chugoku Region, Kyushu Region, Japan

Outcomes

Primary Outcomes

Incidences of Adverse Events

Time frame: 52 weeks

Secondary Outcomes

Change From Baseline in HbA1c at 52 Weeks

Time frame: at week 0 and week 52

Data from ClinicalTrials.gov

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