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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-513 10 mg, once a day, for 4 weeks | Experimental |
| |
| MP-513 20 mg, once a day, for 4 weeks | Experimental |
| |
| Placebo of MP-513 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-513 | Drug | MP-513 10 mg, once a day, for 4 weeks |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-h Mean Glucose | 4 weeks | |
| Change From Baseline in Fasting Plasma Glucose | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Tadashi Yoshida, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suita | Osaka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22776014 | Result | Eto T, Inoue S, Kadowaki T. Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2012 Nov;14(11):1040-6. doi: 10.1111/j.1463-1326.2012.01662.x. Epub 2012 Jul 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-513 10 mg | MP-513 10 mg once a day for 4 weeks |
| FG001 | MP-513 20 mg | MP-513 20 mg once a day for 4 weeks |
| FG002 | Placebo of MP-513 | Placebo of MP-513 a day for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-513 10 mg | MP-513 10 mg once a day for 4 weeks |
| BG001 | MP-513 20 mg | MP-513 20 mg once a day for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner) | Posted | Least Squares Mean | Standard Error | mg / dL | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MP-513 10 mg | MP-513 10 mg once a day for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth abscess | Infections and infestations | MedDRA 13.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| MP-513 |
| Drug |
MP-513 20 mg, once a day, for 4 weeks |
|
| Placebo of MP-513 | Drug | MP-513 placebo, once a day, for 4 weeks |
|
| BG002 |
| Placebo of MP-513 |
Placebo of MP-513 a day for 4 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in 24-h Mean Glucose | Posted | Least Squares Mean | Standard Error | mg / dL | 4 weeks |
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose | Posted | Least Squares Mean | Standard Error | mg / dL | 4 weeks |
|
|
|
| Primary | Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner) | Posted | Least Squares Mean | Standard Error | mg・h / dL | 4 weeks |
|
|
|
| 0 |
| 34 |
| 8 |
| 34 |
| EG001 | MP-513 20 mg | MP-513 20 mg once a day for 4 weeks | 0 | 33 | 6 | 33 |
| EG002 | Placebo of MP-513 | Placebo of MP-513 a day for 4 weeks | 0 | 32 | 9 | 32 |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 |
|
| Haematocrit decreased | Investigations | MedDRA 13.1 |
|
| Haemoglobin decreased | Investigations | MedDRA 13.1 |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 |
|
| Blood triglycerides increased | Investigations | MedDRA 13.1 |
|
| Glucose urine present | Investigations | MedDRA 13.1 |
|
| Blood urine present | Investigations | MedDRA 13.1 |
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| Protein urine present | Investigations | MedDRA 13.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
|
| Plasma Glucose AUC (dinner) |
|