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The purpose of this study is to evaluate the efficacy and safety of Teneligliptin in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration and to evaluate the safety and efficacy of Teneligliptin in combination with Insulin with an extension treatment for up to 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teneli (Teneligliptin) /Teneli + insulin | Experimental | Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin. |
|
| Placebo/Teneli (Teneligliptin) + insulin | Placebo Comparator | Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teneli (Teneligliptin) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c | 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 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate. | at Week 0 and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose | The change from Baseline in Fasting Plasma Glucose collected at Week 16. 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. | at Week 0 and Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Investigational site | Chuo-ku | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28741385 | Result | Kadowaki T, Kondo K, Sasaki N, Miyayama K, Yokota S, Terata R, Gouda M. Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period. Expert Opin Pharmacother. 2017 Sep;18(13):1291-1300. doi: 10.1080/14656566.2017.1359259. Epub 2017 Aug 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Teneli (Teneligliptin) + Insulin | Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin. |
| FG001 | Teneli (Teneligliptin) /Teneli + Insulin | Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1：Double-blind Period |
|
| |||||||||||||||||||||
| Period 2：Open-label Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Teneli (Teneligliptin) + Insulin | Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin. |
| BG001 | Teneli (Teneligliptin) /Teneli + Insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c | 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 16. 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 post baseline double-blind observed value was carried forward and used for Week 16 where data was missing. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | at Week 0 and Week 16 |
|
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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/Teneli (Teneligliptin) + Insulin(Data Through Week 16) | Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA/J 18.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J 18.1 |
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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 |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
|
| Insulin | Drug |
|
| Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose |
The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. 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. |
| 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16 |
| Change From Baseline in 2-hour Postprandial Plasma Glucose | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. 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. | at Week 0 and Week 16 |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| stopping criteria |
|
| NOT COMPLETED |
|
|
Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Teneli (Teneligliptin) /Teneli + Insulin | Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin. |
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose | The change from Baseline in Fasting Plasma Glucose collected at Week 16. 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 post baseline double-blind observed value was carried forward and used for Week 16 where data was missing. | Posted | Least Squares Mean | Standard Error | mg/dL | at Week 0 and Week 16 |
|
|
|
| Secondary | Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose | The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. 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*hr/dL | 0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16 |
|
|
|
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose | The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. 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 | at Week 0 and Week 16 |
|
|
|
| 2 |
| 71 |
| 18 |
| 71 |
| EG001 | Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16) | Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown. | 1 | 77 | 14 | 77 |
| EG002 | Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52) | Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown. | 5 | 63 | 25 | 63 |
| EG003 | Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52) | Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown. | 5 | 77 | 45 | 77 |
| Laryngeal cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J 18.1 |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA/J 18.1 |
|
| Bronchitis | Infections and infestations | MedDRA/J 18.1 |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J 18.1 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J 18.1 |
|
| Cataract | Eye disorders | MedDRA/J 18.1 |
|
| Macular fibrosis | Eye disorders | MedDRA/J 18.1 |
|
| Diabetic retinopathy | Eye disorders | MedDRA/J 18.1 |
|
| Vitreous haemorrhage | Eye disorders | MedDRA/J 18.1 |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA/J 18.1 |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA/J 18.1 |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA/J 18.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA/J 18.1 |
|
| Bronchitis | Infections and infestations | MedDRA/J 18.1 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/J 18.1 |
|
| Pharyngitis | Infections and infestations | MedDRA/J 18.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA/J 18.1 |
|
| Dental caries | Gastrointestinal disorders | MedDRA/J 18.1 |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |