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The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin (LAF237) | Experimental | Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
|
| Placebo | Placebo Comparator | In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin (LAF237) | Drug | Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups | HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory. | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Meeting Responder Rates in HbA1c | Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fukuoka | Fukuoka | 810-8798 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26620049 | Derived | Hirose T, Suzuki M, Tsumiyama I. Efficacy and Safety of Vildagliptin as an Add-on to Insulin with or without Metformin in Japanese Patients with Type 2 Diabetes Mellitus: A 12-week, Double-Blind, Randomized Study. Diabetes Ther. 2015 Dec;6(4):559-571. doi: 10.1007/s13300-015-0147-6. Epub 2015 Nov 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vildagliptin (LAF237) | Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo of vildagliptin 50 mg twice daily |
|
| Insulin | Drug | Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons. The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion. |
|
| Metformin | Drug | Patients continued their prescribed metformin dose, if applicable. |
|
| Baseline, week 12 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks | FPG was performed on a blood sample obtained and analyzed at a central laboratory. | Baseline, week 12 |
| Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia | Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2) | 12 weeks |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. | 12 weeks |
| Fukuoka |
| Fukuoka |
| 815-0071 |
| Japan |
| Novartis Investigative Site | Fukutsu | Fukuoka | 811-3217 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 800-0295 | Japan |
| Novartis Investigative Site | Kōriyama | Fukushima | 963-8851 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 311-4153 | Japan |
| Novartis Investigative Site | Ibusuki | Kagoshima-ken | 891-0401 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0802 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 861-8039 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 861-8520 | Japan |
| Novartis Investigative Site | Yatsushiro | Kumamoto | 866-8533 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 615-0035 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 980-0021 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-0153 | Japan |
| Novartis Investigative Site | Izumisano | Osaka | 598-8577 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 530-0001 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 534-0021 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1096 | Japan |
| Novartis Investigative Site | Ageo | Saitama | 362-8588 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 336-0963 | Japan |
| Novartis Investigative Site | Sayama | Saitama | 350-1305 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1161 | Japan |
| Novartis Investigative Site | Adachi-ku | Tokyo | 123-0845 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 101-0024 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0027 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 103-0028 | Japan |
| Novartis Investigative Site | Chuo-ku | Tokyo | 104-0061 | Japan |
| Novartis Investigative Site | Nerima-ku | Tokyo | 177-0041 | Japan |
| Novartis Investigative Site | Nerima-ku | Tokyo | 177-0051 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 144-0051 | Japan |
| Novartis Investigative Site | Suginami-ku | Tokyo | 166-0004 | Japan |
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vildagliptin (LAF237) | Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
| BG001 | Placebo | In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups | HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory. | The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Baseline, week 12 |
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| Secondary | Percentage of Patients Meeting Responder Rates in HbA1c | Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements. | The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. | Posted | Number | percentage of patients | Baseline, week 12 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks | FPG was performed on a blood sample obtained and analyzed at a central laboratory. | The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. Number of patients with observations at both baseline and endpoint are analyzed in this endpoint. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, week 12 |
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| Secondary | Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia | Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2) | The safety set consisted of all patients who received at least one dose of study medication. | Posted | Number | Participants | 12 weeks |
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| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Death | The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. | The safety set consisted of all patients who received at least one dose of study medication. | Posted | Number | Participants | 12 weeks |
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The safety set consisted of all patients who received at least one dose of study medication. Patients were analyzed according to the treatment received.
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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 | Vildagliptin (LAF237) | Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study | 2 | 78 | 22 | 78 | ||
| EG001 | Placebo | In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study | 1 | 78 | 21 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Hunger | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| D007328 | Insulin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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| Male |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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