Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

Kissei Pharmaceutical Co., Ltd.178 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

Study Type

INTERVENTIONAL

Enrollment

178

Conditions

Type 2 Diabetes Mellitus

Interventions

KAD-1229DRUG

PlaceboDRUG

InsulinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start * Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0% Exclusion Criteria: * Type 1 Diabetes Mellitus * Patients with serious diabetic complications and other serious complications

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Change From Baseline in HbA1c

Time frame: 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.