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The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin 10 mg | Experimental | Teneligliptin 10 mg, orally, once daily |
|
| Teneligliptin 20 mg | Experimental | Teneligliptin 20 mg, orally, once daily |
|
| Teneligliptin 40 mg | Experimental | Teneligliptin 40 mg, orally, once daily |
|
| Placebo | Placebo Comparator | Teneligliptin placebo-matching tablets, orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin 10mg | Drug |
|
| |
| Teneligliptin 20 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, Professor, MD,PhD | Tokyo University | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Tadashi Yoshida, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takikawa-shi | Hokkaido | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Teneligliptin placebo-matching tablets, orally, once daily |
| FG001 | Teneligliptin 10 mg | Teneligliptin 10 mg, orally, once daily |
| FG002 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily |
| FG003 | Teneligliptin 40 mg | Teneligliptin 40 mg, orally, once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Teneligliptin placebo-matching tablets, orally, once daily |
| BG001 | Teneligliptin 10 mg | Teneligliptin 10 mg, orally, once daily |
| 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 HbA1c at Week 12 | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | Posted | Least Squares Mean | Standard Error | Percent | 12 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 | Placebo | Teneligliptin placebo-matching tablets, orally, once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillitis | Infections and infestations | MedDRA (11.1) |
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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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| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
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| Drug |
|
|
| Teneligliptin 40 mg | Drug |
|
|
| Placebo | Drug |
|
| Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 |
The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. |
| 12 weeks |
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. | 12 weeks |
| Physician Decision |
|
| BG002 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily |
| BG003 | Teneligliptin 40 mg | Teneligliptin 40 mg, orally, once daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Teneligliptin 10 mg | Teneligliptin 10 mg, orally, once daily |
| OG002 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily |
| OG003 | Teneligliptin 40 mg | Teneligliptin 40 mg, orally, once daily |
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 12 | The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate. | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing. | Posted | Least Squares Mean | Standard Error | mg / dL | 12 weeks |
|
|
|
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate. | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. | Posted | Least Squares Mean | Standard Error | mg / dL | 12 weeks |
|
|
|
| Secondary | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate. | The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. | Posted | Least Squares Mean | Standard Error | mg*h / dL | 12 weeks |
|
|
|
| 1 |
| 80 |
| 44 |
| 80 |
| EG001 | Teneligliptin 10 mg | Teneligliptin 10 mg, orally, once daily | 0 | 84 | 50 | 84 |
| EG002 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily | 0 | 79 | 40 | 79 |
| EG003 | Teneligliptin 40 mg | Teneligliptin 40 mg, orally, once daily | 0 | 81 | 46 | 81 |
| Bronchitis | Infections and infestations | MedDRA (11.1) |
|
| Chronic sinusitis | Infections and infestations | MedDRA (11.1) |
|
| Cystitis | Infections and infestations | MedDRA (11.1) |
|
| Fungal skin infection | Infections and infestations | MedDRA (11.1) |
|
| Herpes zoster | Infections and infestations | MedDRA (11.1) |
|
| Hordeolum | Infections and infestations | MedDRA (11.1) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) |
|
| Onychomycosis | Infections and infestations | MedDRA (11.1) |
|
| Paronychia | Infections and infestations | MedDRA (11.1) |
|
| Pharyngitis | Infections and infestations | MedDRA (11.1) |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) |
|
| Rhinitis | Infections and infestations | MedDRA (11.1) |
|
| Tinea pedis | Infections and infestations | MedDRA (11.1) |
|
| Tonsillitis | Infections and infestations | MedDRA (11.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) |
|
| Acarodermatitis | Infections and infestations | MedDRA (11.1) |
|
| Oral herpes | Infections and infestations | MedDRA (11.1) |
|
| Tinea manuum | Infections and infestations | MedDRA (11.1) |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (11.1) |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.1) |
|
| Hypothyroidism | Endocrine disorders | MedDRA (11.1) |
|
| Gout | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (11.1) |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (11.1) |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) |
|
| Headache | Nervous system disorders | MedDRA (11.1) |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) |
|
| Migraine | Nervous system disorders | MedDRA (11.1) |
|
| Neuralgia | Nervous system disorders | MedDRA (11.1) |
|
| Somnolence | Nervous system disorders | MedDRA (11.1) |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (11.1) |
|
| Blepharitis | Eye disorders | MedDRA (11.1) |
|
| Cataract | Eye disorders | MedDRA (11.1) |
|
| Conjunctivitis | Eye disorders | MedDRA (11.1) |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (11.1) |
|
| Diabetic retinopathy | Eye disorders | MedDRA (11.1) |
|
| Dry eye | Eye disorders | MedDRA (11.1) |
|
| Glaucoma | Eye disorders | MedDRA (11.1) |
|
| Keratitis | Eye disorders | MedDRA (11.1) |
|
| Keratoconjunctivitis sicca | Eye disorders | MedDRA (11.1) |
|
| Macular degeneration | Eye disorders | MedDRA (11.1) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) |
|
| Hypotension | Vascular disorders | MedDRA (11.1) |
|
| Neurogenic shock | Vascular disorders | MedDRA (11.1) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.1) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (11.1) |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.1) |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (11.1) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Flatulence | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA (11.1) |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Tooth loss | Gastrointestinal disorders | MedDRA (11.1) |
|
| Dyschezia | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (11.1) |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (11.1) |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Urticaria thermal | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (11.1) |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (11.1) |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA (11.1) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (11.1) |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (11.1) |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (11.1) |
|
| Chills | General disorders | MedDRA (11.1) |
|
| Fatigue | General disorders | MedDRA (11.1) |
|
| Malaise | General disorders | MedDRA (11.1) |
|
| Oedema peripheral | General disorders | MedDRA (11.1) |
|
| Pain | General disorders | MedDRA (11.1) |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.1) |
|
| Blood creatinine increased | Investigations | MedDRA (11.1) |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (11.1) |
|
| Blood potassium increased | Investigations | MedDRA (11.1) |
|
| Blood triglycerides increased | Investigations | MedDRA (11.1) |
|
| Blood uric acid increased | Investigations | MedDRA (11.1) |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.1) |
|
| Glucose urine present | Investigations | MedDRA (11.1) |
|
| Blood urine present | Investigations | MedDRA (11.1) |
|
| White blood cell count increased | Investigations | MedDRA (11.1) |
|
| Protein urine present | Investigations | MedDRA (11.1) |
|
| Urobilin urine present | Investigations | MedDRA (11.1) |
|
| Urine ketone body present | Investigations | MedDRA (11.1) |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.1) |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Deafness traumatic | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |