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

Kissei

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: KAD-1229; Drug: Insulin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02154347

KAD6401

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

178 participants in 2 patient groups

KAD-1229/KAD-1229

Experimental group

Description:

Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study.

Treatment:

Drug: KAD-1229

Drug: Insulin

Placebo/KAD-1229

Other group

Description:

Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study.

Treatment:

Drug: KAD-1229

Drug: Insulin

Drug: Placebo