VIDA: Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Vildagliptin Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day |
Drug: Vildagliptin
Orally active and highly selective inhibitor of DPP-4
Drug: Insulin
Long- acting human insulin analog indicated to improve glycemic control
|
Placebo Comparator: Placebo Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid) |
Drug: Insulin
Long- acting human insulin analog indicated to improve glycemic control
Drug: Placebo
Matching placebo of vildagliptin
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with hyperglycemic events evaluated with CGM [At 13 weeks]
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.
Secondary Outcome Measures
- Number of hypoglycemia and/or hyperglycemia measured by CGM [13 weeks]
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.
- Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day [0 to 24 hours daily for week 1, 4 and 13]
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
- Average of insulin units per day administered during the study [13 weeks]
Change from baseline
- Changes from the baseline in Lipid Profile [Baseline, 13 weeks]
Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
- Change from baseline in Body weight [Baseline, 13 weeks]
Weight will be measured on Kg.
- Change from baseline in Blood pressure (BP), [Baseline, 13 weeks]
BP will be mesured on mmHg
- Change from baseline in Fasting plasma glucose (FPG), [Baseline, 13 weeks]
FPG will be measured on mg/dL
- Change from baseline in Hemoglobin A1C (HbA1c) [Baseline, 13 weeks]
HbA1c will be measured on %
- Change from baseline in Creatinine [Baseline, 13 weeks]
Creatinine will be measured on mg/dL
- Change from baseline in C-peptide [Baseline, 13 weeks]
C-Peptide will be measured on microIU/mL
- Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) [Baseline, 13 week]
ALT/AST will be measured on ratio.
- Changes from baseline in Direct bilirubin [Baseline, 13 weeks]
Bilirubin will be measure on mg/dL
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent read and signed before any protocol procedure.
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Free will to sign the informed consent.
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Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
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Type 2 diabetes mellitus
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Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
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HbA1c between 7.5 to 9%.
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Fasting plasma glucose (FPG) less than 270 mg/dL.
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Body mass index (BMI) between 20 to 35 kg/m2.
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Free willing to take the vildagliptin tablets during the study.
Exclusion Criteria
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Pregnant or lactating female or without birth control method if of childbearing potential.
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Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
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Acute cardiovascular complications or metabolic complications within the past 4 months.
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History cerebrovascular disease during the last year.
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History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
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Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
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Congestive heart failure requiring pharmacologic treatment.
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Any known serious heart condition.
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ALT and/or AST greater than three times the upper limit of the normal range.
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Serum creatinine levels greater than 1.5 mg/dL
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Malignancy including leukemia and lymphoma within the last 5 years
Other inlcusion/exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Novartis Investigative Site | Mexico | Distrito Federal | Mexico | 06700 |
2 | Novartis Investigative Site | Mexico | Distrito Federal | Mexico | 07300 |
3 | Novartis Investigative Site | Mexico | Distrito Federal | Mexico | 14050 |
4 | Novartis Investigative Site | Metepec | Estado De México | Mexico | 52140 |
5 | Novartis Investigative Site | Celaya | Guanajuato | Mexico | 38000 |
6 | Novartis Investigative Site | Guadalajara | Jalisco | Mexico | 44150 |
7 | Novartis Investigative Site | Guadalajara | Jalisco | Mexico | 44600 |
8 | Novartis Investigative Site | Guadalajara | Jalisco | Mexico | 44670 |
9 | Novartis Investigative Site | Monterrey | Nuevo Leon | Mexico | 64710 |
10 | Novartis Investigative Site | Monterrey | Nuevo León | Mexico | 64020 |
11 | Novartis Investigative Site | Cancun | Quintana Roo | Mexico | 77500 |
12 | Novartis Investigative Site | Culiacán | Sinaloa | Mexico | 80000 |
13 | Novartis Investigative Site | Puebla | Mexico | 72190 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLAF237AMX01