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The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMF237 50/250 mg | Experimental | Patients took LMF237 50/250 mg twice daily for 14 weeks |
|
| LMF237 50/500 mg | Experimental | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks |
|
| Placebo | Placebo Comparator | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMF237 50/250 mg | Drug | Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups | HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory. | Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups | HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory. | Baseline to 14 weeks |
| Percentage of Patients Meeting Responder Rates in HbA1c |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Chikushino-shi | Fukuoka | 818-0083 | Japan | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | LMF237 50/250 mg | Patients took LMF237 50/250 mg twice daily for 14 weeks |
| FG001 | LMF237 50/500 mg | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| LMF237 50/500 mg | Drug | Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily |
|
| Placebo | Drug | Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily |
|
Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%. Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements. |
| Baseline, 14 weeks |
| Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks | FPG was performed on a blood sample obtained and analyzed at a central laboratory. | Baseline to 14 weeks |
| Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death | The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), 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. | 14 weeks |
| Fukuoka |
| Fukuoka |
| 810-0014 |
| Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 819-0006 | Japan |
| Novartis Investigative Site | Iizuka | Fukuoka | 820-8505 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 800-0296 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 807-0857 | Japan |
| Novartis Investigative Site | Koga | Ibaraki | 306-0232 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0852 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 221-0802 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 231-0023 | Japan |
| Novartis Investigative Site | Yatsushiro | Kumamoto | 866-8533 | Japan |
| Novartis Investigative Site | Yatsushiro | Kumamoto | 866-8660 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 607-8062 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 615-0035 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 590-0064 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1096 | Japan |
| Novartis Investigative Site | Ageo | Saitama | 362-8588 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1161 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-0031 | Japan |
| Novartis Investigative Site | Edogawa-ku | Tokyo | 134-0084 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0046 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Katsushika-ku | Tokyo | 124-0024 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-0021 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 105-7390 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-0075 | Japan |
| Novartis Investigative Site | Nerima-ku | Tokyo | 177-0051 | Japan |
| Novartis Investigative Site | Shibuya-ku | Tokyo | 150-0002 | Japan |
| Novartis Investigative Site | Shinagawa-ku | Tokyo | 141-0032 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0021 | Japan |
| FG002 | Placebo | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks |
| COMPLETED |
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| NOT COMPLETED |
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|
Randomized Set
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| ID | Title | Description |
|---|---|---|
| BG000 | LMF237 50/250 mg | Patients took LMF237 50/250 mg twice daily for 14 weeks |
| BG001 | LMF237 50/500 mg | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks |
| BG002 | Placebo | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks |
| BG003 | 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 14 Weeks Between Treatment Groups | HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory. | Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Baseline to 14 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups | HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory. | Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | Baseline to 14 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Meeting Responder Rates in HbA1c | Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%. Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements. | The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement. | Posted | Number | Percentage of patients | Baseline, 14 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks | FPG was performed on a blood sample obtained and analyzed at a central laboratory. | FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline to 14 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death | The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), 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. | Safety set (SAF): consists of all patients who received at least one dose of study medication. | Posted | Number | Patients | 14 weeks |
|
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Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
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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 | POOLED LMF237 | All patients who has received LMF237 | 1 | 115 | 22 | 115 | ||
| EG001 | LMF237 50/250mg | Patients took LMF237 50/250 mg twice daily for 14 weeks | 0 | 56 | 7 | 56 | ||
| EG002 | LMF237 50/500mg | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks | 1 | 59 | 15 | 59 | ||
| EG003 | Placebo | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks | 2 | 56 | 17 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epiglottitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system 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 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Participants |
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