Back to resultsPost-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
KAD-1229
Placebo
Insulin
Sponsored by
About this trial
This is an interventional trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, HbA1c
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
KAD-1229/KAD-1229
Placebo/KAD-1229
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in HbA1c
Secondary Outcome Measures
Full Information
NCT ID
NCT02154347
First Posted
May 30, 2014
Last Updated
September 4, 2019
Sponsor
Kissei Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02154347
Brief Title
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kissei Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, HbA1c
7. Study Design
Study Phase
Phase 4
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KAD-1229/KAD-1229
Arm Type
Experimental
Arm 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.
Arm Title
Placebo/KAD-1229
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
KAD-1229
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
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
Facility Information:
City
Multiple Locations
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
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