Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Teneli (Teneligliptin)
Placebo
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients whose HbA1c is between 7.5% and 10.5%
- Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion Criteria:
- Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
- Patients who are accepting treatments of arrhythmias
- Patients with serious diabetic complications
- Patients who are the excessive alcohol addicts
- Patients with severe hepatic disorder or severe renal disorder.
- Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Teneli (Teneligliptin) /Teneli + insulin
Placebo/Teneli (Teneligliptin) + insulin
Arm Description
Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Outcomes
Primary Outcome Measures
Change From Baseline in HbA1c
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose
The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.
Change From Baseline in 2-hour Postprandial Plasma Glucose
The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
Full Information
NCT ID
NCT02081599
First Posted
March 5, 2014
Last Updated
August 21, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02081599
Brief Title
Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
Official Title
A Phase IV Study of Teneligliptin (MP-513) in Combination With Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teneli (Teneligliptin) /Teneli + insulin
Arm Type
Experimental
Arm Description
Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Arm Title
Placebo/Teneli (Teneligliptin) + insulin
Arm Type
Placebo Comparator
Arm Description
Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.
Intervention Type
Drug
Intervention Name(s)
Teneli (Teneligliptin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c
Description
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Time Frame
at Week 0 and Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose
Description
The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
Time Frame
at Week 0 and Week 16
Title
Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose
Description
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.
Time Frame
0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16
Title
Change From Baseline in 2-hour Postprandial Plasma Glucose
Description
The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
Time Frame
at Week 0 and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Patients whose HbA1c is between 7.5% and 10.5%
Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Exclusion Criteria:
Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
Patients who are accepting treatments of arrhythmias
Patients with serious diabetic complications
Patients who are the excessive alcohol addicts
Patients with severe hepatic disorder or severe renal disorder.
Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Kadowaki, Professor
Organizational Affiliation
Tokyo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
28741385
Citation
Kadowaki T, Kondo K, Sasaki N, Miyayama K, Yokota S, Terata R, Gouda M. Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period. Expert Opin Pharmacother. 2017 Sep;18(13):1291-1300. doi: 10.1080/14656566.2017.1359259. Epub 2017 Aug 10.
Results Reference
result
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Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes
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