Type 2 Diabetes Mellitus
Conditions
Keywords
insulin resistance
Brief summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.
Interventions
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) 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 * Patients whose HbA1c is between 6.5% - 10.0% * 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 habitual excessive alcohol consumption. * 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 52 weeks |
| Change From Baseline in Fasting Plasma Glucose at Week 52 | Baseline and 52 weeks |
| Change From Baseline in Fasting Glucagon at Week 52 | Baseline and 52 weeks |
| Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | Baseline and 52 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teneligliptin teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) | 212 |
| Teneligliptin and Glinide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide | 80 |
| Teneligliptin and Biguanide teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide | 95 |
| Teneligliptin and Alpha-glucosidase Inhibitor teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor | 75 |
| Total | 462 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 5 | 5 | 5 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 0 |
| Overall Study | Personal matter | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Teneligliptin | Teneligliptin and Glinide | Teneligliptin and Biguanide | Teneligliptin and Alpha-glucosidase Inhibitor | Total |
|---|---|---|---|---|---|
| Age, Customized <65 years | 141 participants | 45 participants | 66 participants | 39 participants | 291 participants |
| Age, Customized >=65 years | 71 participants | 35 participants | 29 participants | 36 participants | 171 participants |
| Sex: Female, Male Female | 71 Participants | 31 Participants | 37 Participants | 25 Participants | 164 Participants |
| Sex: Female, Male Male | 141 Participants | 49 Participants | 58 Participants | 50 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 182 / 212 | 72 / 80 | 81 / 95 | 59 / 75 |
| serious Total, serious adverse events | 14 / 212 | 3 / 80 | 6 / 95 | 6 / 75 |
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 | 14 participants |
| Teneligliptin | Number of Participants With Adverse Events | Other Adverse Event | 182 participants |
| Teneligliptin and Glinide | Number of Participants With Adverse Events | Other Adverse Event | 72 participants |
| Teneligliptin and Glinide | Number of Participants With Adverse Events | Serious Adverse Event | 3 participants |
| Teneligliptin and Biguanide | Number of Participants With Adverse Events | Serious Adverse Event | 6 participants |
| Teneligliptin and Biguanide | Number of Participants With Adverse Events | Other Adverse Event | 81 participants |
| Teneligliptin and Alpha-glucosidase Inhibitor | Number of Participants With Adverse Events | Serious Adverse Event | 6 participants |
| Teneligliptin and Alpha-glucosidase Inhibitor | Number of Participants With Adverse Events | Other Adverse Event | 59 participants |
Secondary
Change From Baseline in Fasting Glucagon at Week 52
Time frame: Baseline and 52 weeks
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 Glucagon at Week 52 | 2.8 pg / mL | Standard Deviation 12.5 |
| Teneligliptin and Glinide | Change From Baseline in Fasting Glucagon at Week 52 | 5.3 pg / mL | Standard Deviation 13.7 |
| Teneligliptin and Biguanide | Change From Baseline in Fasting Glucagon at Week 52 | 5.0 pg / mL | Standard Deviation 14.4 |
| Teneligliptin and Alpha-glucosidase Inhibitor | Change From Baseline in Fasting Glucagon at Week 52 | 6.9 pg / mL | Standard Deviation 15.2 |
Secondary
Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
Time frame: Baseline and 52 weeks
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 Immuno Reactive Insulin (IRI) at Week 52 | 0.988 μU / mL | Standard Deviation 8.314 |
| Teneligliptin and Glinide | Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | 0.211 μU / mL | Standard Deviation 2.378 |
| Teneligliptin and Biguanide | Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | -0.173 μU / mL | Standard Deviation 9.093 |
| Teneligliptin and Alpha-glucosidase Inhibitor | Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52 | -0.330 μU / mL | Standard Deviation 2.713 |
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 52
Time frame: Baseline and 52 weeks
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 | -11.7 mg / dL | Standard Deviation 25.5 |
| Teneligliptin and Glinide | Change From Baseline in Fasting Plasma Glucose at Week 52 | -13.7 mg / dL | Standard Deviation 23.7 |
| Teneligliptin and Biguanide | Change From Baseline in Fasting Plasma Glucose at Week 52 | -12.7 mg / dL | Standard Deviation 27.1 |
| Teneligliptin and Alpha-glucosidase Inhibitor | Change From Baseline in Fasting Plasma Glucose at Week 52 | -19.5 mg / dL | Standard Deviation 23.5 |
Secondary
Change From Baseline in HbA1c at Week 52
Time frame: Baseline and 52 weeks
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 0.64 |
| Teneligliptin and Glinide | Change From Baseline in HbA1c at Week 52 | -0.76 Percent | Standard Deviation 0.7 |
| Teneligliptin and Biguanide | Change From Baseline in HbA1c at Week 52 | -0.78 Percent | Standard Deviation 0.75 |
| Teneligliptin and Alpha-glucosidase Inhibitor | Change From Baseline in HbA1c at Week 52 | -0.89 Percent | Standard Deviation 0.64 |