Trial Outcomes & Findings for Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus (NCT NCT01072331)
NCT ID: NCT01072331
Last Updated: 2026-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
99 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-01-02
Participant Flow
Participant milestones
| Measure |
MP-513 10 mg
MP-513 10 mg once a day for 4 weeks
|
MP-513 20 mg
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
Placebo of MP-513 a day for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
32
|
|
Overall Study
COMPLETED
|
34
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
MP-513 10 mg
n=34 Participants
MP-513 10 mg once a day for 4 weeks
|
MP-513 20 mg
n=33 Participants
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 Participants
Placebo of MP-513 a day for 4 weeks
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.5 • n=228 Participants
|
57.1 years
STANDARD_DEVIATION 8.7 • n=115 Participants
|
58.6 years
STANDARD_DEVIATION 8.9 • n=343 Participants
|
57.2 years
STANDARD_DEVIATION 9.8 • n=18 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=228 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=343 Participants
|
15 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=228 Participants
|
29 Participants
n=115 Participants
|
26 Participants
n=343 Participants
|
84 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
MP-513 20 mg
n=33 Participants
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 Participants
Placebo of MP-513 a day for 4 weeks
|
MP-513 10 mg
n=34 Participants
MP-513 10 mg once a day for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
2-h Postprandial Glucose (lunch)
|
-36.9 mg / dL
Standard Error 7.0
|
-8.3 mg / dL
Standard Error 7.0
|
-43.1 mg / dL
Standard Error 6.5
|
|
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
|
-5.5 mg / dL
Standard Error 6.0
|
-56.2 mg / dL
Standard Error 5.5
|
|
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
|
-4.3 mg / dL
Standard Error 5.8
|
-41.8 mg / dL
Standard Error 5.4
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
MP-513 20 mg
n=33 Participants
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 Participants
Placebo of MP-513 a day for 4 weeks
|
MP-513 10 mg
n=34 Participants
MP-513 10 mg once a day for 4 weeks
|
|---|---|---|---|
|
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
|
-8.950 mg・h / dL
Standard Error 8.294
|
-82.114 mg・h / dL
Standard Error 8.028
|
|
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
|
-6.884 mg・h / dL
Standard Error 11.184
|
-92.947 mg・h / dL
Standard Error 10.592
|
|
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
|
-11.271 mg・h / dL
Standard Error 10.218
|
-75.204 mg・h / dL
Standard Error 9.660
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
MP-513 20 mg
n=33 Participants
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 Participants
Placebo of MP-513 a day for 4 weeks
|
MP-513 10 mg
n=34 Participants
MP-513 10 mg once a day for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in 24-h Mean Glucose
|
-30.921 mg / dL
Standard Error 4.005
|
-5.402 mg / dL
Standard Error 4.037
|
-34.722 mg / dL
Standard Error 3.885
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
MP-513 20 mg
n=33 Participants
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 Participants
Placebo of MP-513 a day for 4 weeks
|
MP-513 10 mg
n=34 Participants
MP-513 10 mg once a day for 4 weeks
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose
|
-20.5 mg / dL
Standard Error 2.8
|
-6.9 mg / dL
Standard Error 2.8
|
-20.7 mg / dL
Standard Error 2.7
|
Adverse Events
MP-513 10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
MP-513 20 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo of MP-513
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MP-513 10 mg
n=34 participants at risk
MP-513 10 mg once a day for 4 weeks
|
MP-513 20 mg
n=33 participants at risk
MP-513 20 mg once a day for 4 weeks
|
Placebo of MP-513
n=32 participants at risk
Placebo of MP-513 a day for 4 weeks
|
|---|---|---|---|
|
Infections and infestations
Tooth abscess
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • 4 weeks
|
6.1%
2/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.8%
3/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • 4 weeks
|
3.0%
1/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Investigations
Haematocrit decreased
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
1/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
1/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/34 • 4 weeks
|
3.0%
1/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Investigations
Glucose urine present
|
2.9%
1/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
9.4%
3/32 • 4 weeks
|
|
Investigations
Blood urine present
|
2.9%
1/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
0.00%
0/32 • 4 weeks
|
|
Investigations
Protein urine present
|
0.00%
0/34 • 4 weeks
|
3.0%
1/33 • 4 weeks
|
6.2%
2/32 • 4 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • 4 weeks
|
0.00%
0/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/34 • 4 weeks
|
3.0%
1/33 • 4 weeks
|
3.1%
1/32 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER