Type 2 Diabetes Mellitus
Conditions
Brief summary
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
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
* A signed and dated informed consent form obtained from the subject, in accordance. * The subject is aged ≥18 years at signature of the informed consent form. * Hospitalization status: outpatient. * The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28). * The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria. * The subject's HbA1c is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.
Exclusion criteria
* The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes. * The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration). * The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Changes in HbA1c at Week 24 | at Day 1(baseline) and Week 24 | The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Changes in Fasting Plasma Glucose (FPG) at Week 24 | at Day 1(baseline) and Week 24 | The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teneligliptin 20mg + Metformin Teneligliptin (20 mg once daily) for 24 weeks in combination with metformin. | 122 |
| Placebo + Metformin Placebo for 24 weeks in combination with metformin. | 124 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 17 | 29 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Placebo + Metformin | Total | Teneligliptin 20mg + Metformin |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.1 | 55.3 years STANDARD_DEVIATION 10 | 56.0 years STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 124 Participants | 246 Participants | 122 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 57 Participants | 98 Participants | 41 Participants |
| Sex: Female, Male Male | 67 Participants | 148 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 123 |
| other Total, other adverse events | 35 / 124 | 43 / 123 |
| serious Total, serious adverse events | 4 / 124 | 6 / 123 |
Outcome results
Primary
The Changes in HbA1c at Week 24
The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time frame: at Day 1(baseline) and Week 24
Population: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teneligliptin 20mg + Metformin | The Changes in HbA1c at Week 24 | -0.72 percentage of HbA1c | Standard Error 0.07 |
| Placebo + Metformin | The Changes in HbA1c at Week 24 | -0.01 percentage of HbA1c | Standard Error 0.07 |
Secondary
The Changes in Fasting Plasma Glucose (FPG) at Week 24
The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS.
Time frame: at Day 1(baseline) and Week 24
Population: All subjects in the randomized set who have received at least one dose of study medication during the double-blind treatment period and have at least one post-baseline efficacy observation. Subjects who were not diagnosed with type 2 diabetes mellitus were excluded.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Teneligliptin 20mg + Metformin | The Changes in Fasting Plasma Glucose (FPG) at Week 24 | -13.5 mg/dL | Standard Error 3.3 |
| Placebo + Metformin | The Changes in Fasting Plasma Glucose (FPG) at Week 24 | 3.0 mg/dL | Standard Error 3.3 |