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Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01072331
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : December 19, 2012
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: MP-513
Drug: Placebo of MP-513
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description MP-513 10 mg once a day for 4 weeks MP-513 20 mg once a day for 4 weeks Placebo of MP-513 a day for 4 weeks
Period Title: Overall Study
Started 34 33 32
Completed 34 33 32
Not Completed 0 0 0
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513 Total
Hide Arm/Group Description MP-513 10 mg once a day for 4 weeks MP-513 20 mg once a day for 4 weeks Placebo of MP-513 a day for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 34 33 32 99
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 32 participants 99 participants
56.1  (11.5) 57.1  (8.7) 58.6  (8.9) 57.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 32 participants 99 participants
Female
5
  14.7%
4
  12.1%
6
  18.8%
15
  15.2%
Male
29
  85.3%
29
  87.9%
26
  81.3%
84
  84.8%
1.Primary Outcome
Title Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)
Hide Description [Not Specified]
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description:
MP-513 10 mg once a day for 4 weeks
MP-513 20 mg once a day for 4 weeks
Placebo of MP-513 a day for 4 weeks
Overall Number of Participants Analyzed 34 33 32
Least Squares Mean (Standard Error)
Unit of Measure: mg / dL
2-h Postprandial Glucose (breakfast) -56.2  (5.5) -43.7  (5.8) -5.5  (6.0)
2-h Postprandial Glucose (lunch) -43.1  (6.5) -36.9  (7.0) -8.3  (7.0)
2-h Postprandial Glucose (dinner) -41.8  (5.4) -40.5  (5.7) -4.3  (5.8)
2.Primary Outcome
Title Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)
Hide Description [Not Specified]
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description:
MP-513 10 mg once a day for 4 weeks
MP-513 20 mg once a day for 4 weeks
Placebo of MP-513 a day for 4 weeks
Overall Number of Participants Analyzed 34 33 32
Least Squares Mean (Standard Error)
Unit of Measure: mg・h / dL
Plasma Glucose AUC (breakfast) -82.114  (8.028) -75.437  (8.321) -8.950  (8.294)
Plasma Glucose AUC (lunch) -92.947  (10.592) -86.843  (11.328) -6.884  (11.184)
Plasma Glucose AUC (dinner) -75.204  (9.660) -85.192  (10.158) -11.271  (10.218)
3.Secondary Outcome
Title Change From Baseline in 24-h Mean Glucose
Hide Description [Not Specified]
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description:
MP-513 10 mg once a day for 4 weeks
MP-513 20 mg once a day for 4 weeks
Placebo of MP-513 a day for 4 weeks
Overall Number of Participants Analyzed 34 33 32
Least Squares Mean (Standard Error)
Unit of Measure: mg / dL
-34.722  (3.885) -30.921  (4.005) -5.402  (4.037)
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose
Hide Description [Not Specified]
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description:
MP-513 10 mg once a day for 4 weeks
MP-513 20 mg once a day for 4 weeks
Placebo of MP-513 a day for 4 weeks
Overall Number of Participants Analyzed 34 33 32
Least Squares Mean (Standard Error)
Unit of Measure: mg / dL
-20.7  (2.7) -20.5  (2.8) -6.9  (2.8)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MP-513 10 mg MP-513 20 mg Placebo of MP-513
Hide Arm/Group Description MP-513 10 mg once a day for 4 weeks MP-513 20 mg once a day for 4 weeks Placebo of MP-513 a day for 4 weeks
All-Cause Mortality
MP-513 10 mg MP-513 20 mg Placebo of MP-513
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MP-513 10 mg MP-513 20 mg Placebo of MP-513
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MP-513 10 mg MP-513 20 mg Placebo of MP-513
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/34 (23.53%)   6/33 (18.18%)   9/32 (28.13%) 
Gastrointestinal disorders       
Diarrhoea  0/34 (0.00%)  1/33 (3.03%)  0/32 (0.00%) 
Colonic polyp  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Infections and infestations       
Tooth abscess  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Nasopharyngitis  2/34 (5.88%)  2/33 (6.06%)  0/32 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Excoriation  0/34 (0.00%)  1/33 (3.03%)  1/32 (3.13%) 
Investigations       
Alanine aminotransferase increased  1/34 (2.94%)  0/33 (0.00%)  0/32 (0.00%) 
Haematocrit decreased  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Haemoglobin decreased  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Gamma-glutamyltransferase increased  1/34 (2.94%)  0/33 (0.00%)  0/32 (0.00%) 
Blood creatine phosphokinase increased  1/34 (2.94%)  0/33 (0.00%)  0/32 (0.00%) 
Blood triglycerides increased  0/34 (0.00%)  1/33 (3.03%)  1/32 (3.13%) 
Glucose urine present  1/34 (2.94%)  0/33 (0.00%)  3/32 (9.38%) 
Blood urine present  1/34 (2.94%)  0/33 (0.00%)  0/32 (0.00%) 
Protein urine present  0/34 (0.00%)  1/33 (3.03%)  2/32 (6.25%) 
Musculoskeletal and connective tissue disorders       
Back pain  0/34 (0.00%)  0/33 (0.00%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract inflammation  3/34 (8.82%)  0/33 (0.00%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01072331     History of Changes
Other Study ID Numbers: 3000-A12
First Submitted: February 18, 2010
First Posted: February 22, 2010
Results First Submitted: November 20, 2012
Results First Posted: December 19, 2012
Last Update Posted: April 9, 2013