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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: KAD-1229; Drug: Placebo; Drug: Insulin

• Registration Number: NCT02154347
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-30
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2016-07
• Status Verified: 2017-05
• Results First Submitted: 2019-07-12
• Results First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Results First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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%

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Exclusion Criteria

• Type 1 Diabetes Mellitus
• Patients with serious diabetic complications and other serious complications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo/KAD-1229	Placebo	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.
Placebo/KAD-1229	KAD-1229	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.
KAD-1229/KAD-1229	Insulin	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.
Placebo/KAD-1229	Insulin	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.
KAD-1229/KAD-1229	KAD-1229	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c	16 weeks