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

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154347
• Other study ID #: KAD6401
• Status: Completed
• Phase: Phase 4

Study information

• Verified date: May 2017
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. primary completion date: July 2016
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• KAD-1229

• Placebo

• Insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c		16 weeks