Type 2 Diabetes Mellitus
Conditions
Keywords
insulin resistance
Brief summary
The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.
Interventions
DRUGMP-513
MP-513 10 mg, once a day, for 4 weeks
DRUGPlacebo of MP-513
MP-513 placebo, once a day, for 4 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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are 20 - 75 years old * Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug * Patients whose HbA1c is ≥6.5% and \<10.0% * Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 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 |
|---|---|
| Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 4 weeks |
| Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in 24-h Mean Glucose | 4 weeks |
| Change From Baseline in Fasting Plasma Glucose | 4 weeks |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MP-513 10 mg MP-513 10 mg once a day for 4 weeks | 34 |
| MP-513 20 mg MP-513 20 mg once a day for 4 weeks | 33 |
| Placebo of MP-513 Placebo of MP-513 a day for 4 weeks | 32 |
| Total | 99 |
Baseline characteristics
| Characteristic | MP-513 10 mg | MP-513 20 mg | Placebo of MP-513 | Total |
|---|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 11.5 | 57.1 years STANDARD_DEVIATION 8.7 | 58.6 years STANDARD_DEVIATION 8.9 | 57.2 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 26 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 34 | 6 / 33 | 9 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 32 |
Outcome results
Primary
Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
Time frame: 4 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MP-513 10 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (lunch) | -43.1 mg / dL | Standard Error 6.5 |
| MP-513 10 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (breakfast) | -56.2 mg / dL | Standard Error 5.5 |
| MP-513 10 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (dinner) | -41.8 mg / dL | Standard Error 5.4 |
| MP-513 20 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (lunch) | -36.9 mg / dL | Standard Error 7 |
| MP-513 20 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (breakfast) | -43.7 mg / dL | Standard Error 5.8 |
| MP-513 20 mg | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (dinner) | -40.5 mg / dL | Standard Error 5.7 |
| Placebo of MP-513 | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (breakfast) | -5.5 mg / dL | Standard Error 6 |
| Placebo of MP-513 | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (dinner) | -4.3 mg / dL | Standard Error 5.8 |
| Placebo of MP-513 | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | 2-h Postprandial Glucose (lunch) | -8.3 mg / dL | Standard Error 7 |
Primary
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)
Time frame: 4 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| MP-513 10 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (breakfast) | -82.114 mg・h / dL | Standard Error 8.028 |
| MP-513 10 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (lunch) | -92.947 mg・h / dL | Standard Error 10.592 |
| MP-513 10 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (dinner) | -75.204 mg・h / dL | Standard Error 9.66 |
| MP-513 20 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (dinner) | -85.192 mg・h / dL | Standard Error 10.158 |
| MP-513 20 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (breakfast) | -75.437 mg・h / dL | Standard Error 8.321 |
| MP-513 20 mg | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (lunch) | -86.843 mg・h / dL | Standard Error 11.328 |
| Placebo of MP-513 | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (dinner) | -11.271 mg・h / dL | Standard Error 10.218 |
| Placebo of MP-513 | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (breakfast) | -8.950 mg・h / dL | Standard Error 8.294 |
| Placebo of MP-513 | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Plasma Glucose AUC (lunch) | -6.884 mg・h / dL | Standard Error 11.184 |
Secondary
Change From Baseline in 24-h Mean Glucose
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP-513 10 mg | Change From Baseline in 24-h Mean Glucose | -34.722 mg / dL | Standard Error 3.885 |
| MP-513 20 mg | Change From Baseline in 24-h Mean Glucose | -30.921 mg / dL | Standard Error 4.005 |
| Placebo of MP-513 | Change From Baseline in 24-h Mean Glucose | -5.402 mg / dL | Standard Error 4.037 |
Secondary
Change From Baseline in Fasting Plasma Glucose
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MP-513 10 mg | Change From Baseline in Fasting Plasma Glucose | -20.7 mg / dL | Standard Error 2.7 |
| MP-513 20 mg | Change From Baseline in Fasting Plasma Glucose | -20.5 mg / dL | Standard Error 2.8 |
| Placebo of MP-513 | Change From Baseline in Fasting Plasma Glucose | -6.9 mg / dL | Standard Error 2.8 |