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The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day |
|
| Placebo | Placebo Comparator | Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Orally active and highly selective inhibitor of DPP-4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with hyperglycemic events evaluated with CGM | An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL. | At 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoglycemia and/or hyperglycemia measured by CGM | An episode of hypoglycemia is defined as any value of glucose under 60 mg/dL, an episode of hyperglycemia is defined as any value of glucose above 140mg/dL measured by CGM. | 13 weeks |
| Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day |
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Inclusion Criteria:
Exclusion Criteria
Other inlcusion/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 | Celaya | Guanajuato | 38000 | Mexico | ||
| Novartis Investigative Site |
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| Insulin |
| Drug |
Long- acting human insulin analog indicated to improve glycemic control |
|
| Placebo | Drug | Matching placebo of vildagliptin |
|
Duration and intensity of hypoglycemic episodes, measured as area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, measured by continuous glucose monitoring |
| 0 to 24 hours daily for week 1, 4 and 13 |
| Average of insulin units per day administered during the study | Change from baseline | 13 weeks |
| Changes from the baseline in Lipid Profile | Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol | Baseline, 13 weeks |
| Change from baseline in Body weight | Weight will be measured on Kg. | Baseline, 13 weeks |
| Change from baseline in Blood pressure (BP), | BP will be mesured on mmHg | Baseline, 13 weeks |
| Change from baseline in Fasting plasma glucose (FPG), | FPG will be measured on mg/dL | Baseline, 13 weeks |
| Change from baseline in Hemoglobin A1C (HbA1c) | HbA1c will be measured on % | Baseline, 13 weeks |
| Change from baseline in Creatinine | Creatinine will be measured on mg/dL | Baseline, 13 weeks |
| Change from baseline in C-peptide | C-Peptide will be measured on microIU/mL | Baseline, 13 weeks |
| Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) | ALT/AST will be measured on ratio. | Baseline, 13 week |
| Changes from baseline in Direct bilirubin | Bilirubin will be measure on mg/dL | Baseline, 13 weeks |
| Changes from baseline in Body Mass Index (BMI) | Baseline, 13 weeks |
| Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin | 13 weeks |
| Guadalajara |
| Jalisco |
| 44150 |
| Mexico |
| Novartis Investigative Site | Guadalajara | Jalisco | 44600 | Mexico |
| Novartis Investigative Site | Guadalajara | Jalisco | 44670 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 06700 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 07300 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 14050 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64020 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64710 | Mexico |
| Novartis Investigative Site | Cancún | Quintana Roo | 77500 | Mexico |
| Novartis Investigative Site | Culiacán | Sinaloa | 80000 | Mexico |
| Novartis Investigative Site | Metepec | State of Mexico | 52140 | Mexico |
| Novartis Investigative Site | Puebla City | 72190 | Mexico |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D007328 | Insulin |
| 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 |
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