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The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCI-196 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCI-196 | Drug | Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose at Baseline | 0 weeks | |
| Change From Baseline in Blood Glucose at Week 12 | 12 weeks (baseline to week 12) | |
| Hemoglobin A1c (HbA1c) at Baseline | 0 weeks | |
| Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 | 12 weeks (baseline to week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 | 12 weeks (baseline to week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20047620 | Result | Kondo K, Kadowaki T. Colestilan monotherapy significantly improves glycaemic control and LDL cholesterol levels in patients with type 2 diabetes: a randomized double-blind placebo-controlled study. Diabetes Obes Metab. 2010 Mar;12(3):246-51. doi: 10.1111/j.1463-1326.2009.01159.x. Epub 2009 Sep 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCI-196 | Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) |
| FG001 | Placebo | Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MCI-196 | Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) |
| BG001 | Placebo | Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 | Posted | Mean | Standard Error | mg/dL | 12 weeks (baseline to week 12) |
|
|
1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
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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 | MCI-196 | Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon polyp | Gastrointestinal disorders | MedDRA 10.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106574 | cholebine |
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| Placebo of MCI-196 Tablet | Drug | Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Fasting Plasma Glucose at Baseline | Per protocol set | Posted | Mean | Standard Deviation | mg/dL | 0 weeks |
|
|
|
| Primary | Change From Baseline in Blood Glucose at Week 12 | Per protocol set; Last observation carried forward | Posted | Mean | Standard Error | mg/dL | 12 weeks (baseline to week 12) |
|
|
|
| Primary | Hemoglobin A1c (HbA1c) at Baseline | Per protocol set | Posted | Mean | Standard Deviation | percentage | 0 weeks |
|
|
|
| Primary | Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 | Per protocol set; Last observation carried forward | Posted | Mean | Standard Error | percentage | 12 weeks (baseline to week 12) |
|
|
|
| 1 |
| 92 |
| 53 |
| 92 |
| EG001 | Placebo | Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration | 5 | 91 | 46 | 91 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 |
|
| Cerebral infarction | Nervous system disorders | MedDRA 10.1 |
|
| Peripheral embolism | Vascular disorders | MedDRA 10.1 |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 10.1 |
|
| Cataract | Eye disorders | MedDRA 10.1 |
|
| Corneal erosion | Eye disorders | MedDRA 10.1 |
|
| Diabetic retinopathy | Eye disorders | MedDRA 10.1 |
|
| Episcleritis | Eye disorders | MedDRA 10.1 |
|
| Eye pain | Eye disorders | MedDRA 10.1 |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.1 |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 10.1 |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 10.1 |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA 10.1 |
|
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 10.1 |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 10.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 10.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.1 |
|
| Pyrexia | General disorders | MedDRA 10.1 |
|
| Acute tonsillitis | Infections and infestations | MedDRA 10.1 |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 |
|
| Cystitis | Infections and infestations | MedDRA 10.1 |
|
| Folliculitis | Infections and infestations | MedDRA 10.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.1 |
|
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA 10.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 10.1 |
|
| Influenza | Infections and infestations | MedDRA 10.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 |
|
| Otitis media | Infections and infestations | MedDRA 10.1 |
|
| Paronychia | Infections and infestations | MedDRA 10.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 10.1 |
|
| Tinea pedis | Infections and infestations | MedDRA 10.1 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 10.1 |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.1 |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 10.1 |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 10.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 |
|
| Oesophageal neoplasma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 10.1 |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA 10.1 |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 |
|
| Dysgeusia | Nervous system disorders | MedDRA 10.1 |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.1 |
|
| Migraine | Nervous system disorders | MedDRA 10.1 |
|
| Sciatica | Nervous system disorders | MedDRA 10.1 |
|
| Tension headache | Nervous system disorders | MedDRA 10.1 |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 10.1 |
|
| Haematuria | Renal and urinary disorders | MedDRA 10.1 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Schamberg's disease | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA 10.1 |
|
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| D004700 | Endocrine System Diseases |