Type 2 Diabetes Mellitus
Conditions
Keywords
DPP-IV inhibitor
Brief summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.
Interventions
DRUGTeneligliptin
Teneligliptin for 52 weeks
DRUGTeneligliptin + Sulfonylurea
Teneligliptin for 52 weeks in combination with sulfonylurea
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* In case of combination therapy with Sulfonylurea, patients who has been receiving a stable dose and regimen of sulfonylurea for diabetes 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 * HbA1c criteria: * monotherapy: 6.9% - 10.5% * combination therapy with Sulfonylurea: 7.4 - 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 52 weeks | Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in HbA1c at Week 52 | Baseline and Week 52 |
| Change From Baseline in Fasting Plasma Glucose at Week 52 | Baseline and Week 52 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teneligliptin Teneligliptin for 52 weeks | 151 |
| Teneligliptin + Sulfonylurea Teneligliptin for 52 weeks in combination with sulfonylurea | 89 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 8 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Other Reason | 1 | 0 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Teneligliptin | Teneligliptin + Sulfonylurea | Total |
|---|---|---|---|
| Age, Customized <65 years | 108 participants | 65 participants | 173 participants |
| Age, Customized >=65 years | 43 participants | 24 participants | 67 participants |
| Sex: Female, Male Female | 56 Participants | 33 Participants | 89 Participants |
| Sex: Female, Male Male | 95 Participants | 56 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 136 / 151 | 84 / 89 |
| serious Total, serious adverse events | 6 / 151 | 7 / 89 |
Outcome results
Primary
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.
Time frame: 52 weeks
Population: Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Teneligliptin | Number of Participants With Adverse Events | Serious Adverse Event | 6 participants |
| Teneligliptin | Number of Participants With Adverse Events | Other Adverse Event | 136 participants |
| Teneligliptin + Sulfonylurea | Number of Participants With Adverse Events | Serious Adverse Event | 7 participants |
| Teneligliptin + Sulfonylurea | Number of Participants With Adverse Events | Other Adverse Event | 84 participants |
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 52
Time frame: Baseline and Week 52
Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teneligliptin | Change From Baseline in Fasting Plasma Glucose at Week 52 | -12.4 mg/dL | Standard Deviation 22.9 |
| Teneligliptin + Sulfonylurea | Change From Baseline in Fasting Plasma Glucose at Week 52 | -17.0 mg/dL | Standard Deviation 30.5 |
Secondary
Change From Baseline in HbA1c at Week 52
Time frame: Baseline and Week 52
Population: The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teneligliptin | Change From Baseline in HbA1c at Week 52 | -0.63 percent | Standard Deviation 0.67 |
| Teneligliptin + Sulfonylurea | Change From Baseline in HbA1c at Week 52 | -0.81 percent | Standard Deviation 0.76 |