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 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.
Interventions
DRUGMP-513 Lowest Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUGMP-513 Low Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUGMP-513 Medium Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUGMP-513 High Dose and Metformin
MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
DRUGPlacebo and Metformin
Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are aged ≧ 18 years old. * Patients whose HbA1c is ≧ 7.0 % and \< 10.0%. * Patients whose BMI is ≧ 20.0 and ≦40.0 ㎏/㎡. * Patients who took metformin monotherapy for at least 56 consecutive days at the screening visit.
Exclusion criteria
* Patients with type 1 diabetes or secondary form of diabetes. * Patients with heart failure symptoms. * Patients with serious diabetic complications. * Patients with severe hepatic disorder or severe renal disorder. * Patients who are the excessive alcohol addicts. * Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c From Baseline to Week 24 | Baseline and Week 24 | The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | Baseline and Week 24 | Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint. |
| Adverse Events, Laboratory Tests, Vital Signs, Etc. | Weeks 24, 52 | — |
Countries
Denmark, Germany, Hungary, Lithuania, Poland, Romania, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teneli 5mg+Met Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin | 87 |
| Teneli 10mg+Met Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin | 93 |
| Teneli 20mg+Met Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin | 91 |
| Teneli 40mg+Met Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin | 88 |
| Placebo+Met Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin | 88 |
| Total | 447 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double Blind Period | Adverse Event | 2 | 3 | 2 | 2 | 3 |
| Double Blind Period | Lost to Follow-up | 0 | 1 | 1 | 0 | 1 |
| Double Blind Period | Other reasons | 1 | 0 | 2 | 0 | 1 |
| Double Blind Period | Physician Decision | 10 | 6 | 7 | 6 | 7 |
| Double Blind Period | Protocol Violation | 2 | 0 | 3 | 2 | 2 |
| Double Blind Period | Withdrawal by Subject | 4 | 1 | 4 | 4 | 4 |
| Open-label Period | Adverse Event | 1 | 0 | 1 | 1 | 0 |
| Open-label Period | Other reason | 0 | 0 | 0 | 0 | 2 |
| Open-label Period | Physician Decision | 5 | 9 | 3 | 7 | 2 |
| Open-label Period | Protocol Violation | 1 | 1 | 1 | 0 | 1 |
| Open-label Period | Withdrawal by Subject | 1 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Teneli 5mg+Met | Teneli 10mg+Met | Teneli 20mg+Met | Teneli 40mg+Met | Placebo+Met | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 7.7 | 58.5 years STANDARD_DEVIATION 8.4 | 58.3 years STANDARD_DEVIATION 9.5 | 58.2 years STANDARD_DEVIATION 8.6 | 58.9 years STANDARD_DEVIATION 8.2 | 58.5 years STANDARD_DEVIATION 8.5 |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 35 Participants | 36 Participants | 41 Participants | 195 Participants |
| Sex: Female, Male Male | 46 Participants | 51 Participants | 56 Participants | 52 Participants | 47 Participants | 252 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 87 | 43 / 93 | 41 / 91 | 36 / 88 | 48 / 88 |
| serious Total, serious adverse events | 4 / 87 | 4 / 93 | 3 / 91 | 5 / 88 | 6 / 88 |
Outcome results
Primary
Change in HbA1c From Baseline to Week 24
The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.
Time frame: Baseline and Week 24
Population: LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teneli 5mg+Met | Change in HbA1c From Baseline to Week 24 | -0.58 percentage of HbA1c | Standard Error 0.07 |
| Teneli 10mg+Met | Change in HbA1c From Baseline to Week 24 | -0.68 percentage of HbA1c | Standard Error 0.07 |
| Teneli 20mg+Met | Change in HbA1c From Baseline to Week 24 | -0.76 percentage of HbA1c | Standard Error 0.07 |
| Teneli 40mg+Met | Change in HbA1c From Baseline to Week 24 | -0.91 percentage of HbA1c | Standard Error 0.07 |
| Placebo+Met | Change in HbA1c From Baseline to Week 24 | -0.28 percentage of HbA1c | Standard Error 0.07 |
Secondary
Adverse Events, Laboratory Tests, Vital Signs, Etc.
Time frame: Weeks 24, 52
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.
Time frame: Baseline and Week 24
Population: LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teneli 5mg+Met | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -15.54 mg/dL | Standard Error 2.94 |
| Teneli 10mg+Met | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -13.65 mg/dL | Standard Error 2.83 |
| Teneli 20mg+Met | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -17.84 mg/dL | Standard Error 2.86 |
| Teneli 40mg+Met | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -21.85 mg/dL | Standard Error 2.91 |
| Placebo+Met | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -3.51 mg/dL | Standard Error 2.95 |