Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneligliptin 20 mg | Experimental | Teneligliptin 20 mg, orally, once daily |
|
| Placebo | Placebo Comparator | Teneligliptin placebo-matching tablets, orally, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneligliptin 20 mg | Drug |
|
| |
| Placebo |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Takashi Kadowaki, Professor | Tokyo University | Study Director |
| Kazuoki Kondo, MD | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Teneligliptin placebo-matching tablets, orally, once daily |
| FG001 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Teneligliptin placebo-matching tablets, orally, once daily |
| BG001 | Teneligliptin 20 mg | Teneligliptin 20 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 |
|
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|
| Vestibular neuronitis | Infections and infestations | MedDRA(13.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA(13.0) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C579035 | 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 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 |
| 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 |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Personal matter |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Teneligliptin 20 mg | Teneligliptin 20 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 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 |
|
|
|
| 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 |
|
|
|
| 4 |
| 104 |
| 63 |
| 104 |
| EG001 | Teneligliptin 20 mg | Teneligliptin 20 mg, orally, once daily | 0 | 99 | 62 | 99 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.0) |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.0) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA(13.0) |
|
| Bronchitis | Infections and infestations | MedDRA(13.0) |
|
| Cystitis | Infections and infestations | MedDRA(13.0) |
|
| Gastroenteritis | Infections and infestations | MedDRA(13.0) |
|
| Hordeolum | Infections and infestations | MedDRA(13.0) |
|
| Influenza | Infections and infestations | MedDRA(13.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA(13.0) |
|
| Pharyngitis | Infections and infestations | MedDRA(13.0) |
|
| Tinea pedis | Infections and infestations | MedDRA(13.0) |
|
| Helicobacter infection | Infections and infestations | MedDRA(13.0) |
|
| Alveolar osteitis | Infections and infestations | MedDRA(13.0) |
|
| Oral herpes | Infections and infestations | MedDRA(13.0) |
|
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.0) |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA(13.0) |
|
| Gout | Metabolism and nutrition disorders | MedDRA(13.0) |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA(13.0) |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA(13.0) |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA(13.0) |
|
| Insomnia | Psychiatric disorders | MedDRA(13.0) |
|
| Anxiety disorder | Psychiatric disorders | MedDRA(13.0) |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA(13.0) |
|
| Dizziness | Nervous system disorders | MedDRA(13.0) |
|
| Headache | Nervous system disorders | MedDRA(13.0) |
|
| Myasthenia gravis | Nervous system disorders | MedDRA(13.0) |
|
| Neuralgia | Nervous system disorders | MedDRA(13.0) |
|
| Blepharospasm | Eye disorders | MedDRA(13.0) |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA(13.0) |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA(13.0) |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA(13.0) |
|
| Palpitations | Cardiac disorders | MedDRA(13.0) |
|
| Hypertension | Vascular disorders | MedDRA(13.0) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA(13.0) |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA(13.0) |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA(13.0) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA(13.0) |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA(13.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA(13.0) |
|
| Dental caries | Gastrointestinal disorders | MedDRA(13.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA(13.0) |
|
| Duodenitis | Gastrointestinal disorders | MedDRA(13.0) |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA(13.0) |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA(13.0) |
|
| Gastritis | Gastrointestinal disorders | MedDRA(13.0) |
|
| Periodontitis | Gastrointestinal disorders | MedDRA(13.0) |
|
| Stomatitis | Gastrointestinal disorders | MedDRA(13.0) |
|
| Toothache | Gastrointestinal disorders | MedDRA(13.0) |
|
| Gastric xanthoma | Gastrointestinal disorders | MedDRA(13.0) |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA(13.0) |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA(13.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA(13.0) |
|
| Micturition disorder | Renal and urinary disorders | MedDRA(13.0) |
|
| Chest pain | General disorders | MedDRA(13.0) |
|
| Feeling abnormal | General disorders | MedDRA(13.0) |
|
| Malaise | General disorders | MedDRA(13.0) |
|
| Vessel puncture site haematoma | General disorders | MedDRA(13.0) |
|
| Alanine aminotransferase increased | Investigations | MedDRA(13.0) |
|
| Aspartate aminotransferase increased | Investigations | MedDRA(13.0) |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA(13.0) |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA(13.0) |
|
| Blood triglycerides increased | Investigations | MedDRA(13.0) |
|
| Blood urea increased | Investigations | MedDRA(13.0) |
|
| Blood uric acid increased | Investigations | MedDRA(13.0) |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA(13.0) |
|
| Glucose urine present | Investigations | MedDRA(13.0) |
|
| Blood urine present | Investigations | MedDRA(13.0) |
|
| White blood cell count increased | Investigations | MedDRA(13.0) |
|
| Protein urine present | Investigations | MedDRA(13.0) |
|
| Urine ketone body present | Investigations | MedDRA(13.0) |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA(13.0) |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA(13.0) |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA(13.0) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA(13.0) |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA(13.0) |
|
Not provided
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |