Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes (VIDA)

A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Vildagliptin; Drug: Insulin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Puebla, Mexico, 72190
    • Novartis Investigative Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14050
      • Novartis Investigative Site
    • Mexico, Distrito Federal, Mexico, 06700
      • Novartis Investigative Site
    • Mexico, Distrito Federal, Mexico, 07300
      • Novartis Investigative Site
  • Estado De México
    • Metepec, Estado De México, Mexico, 52140
      • Novartis Investigative Site
  • Guanajuato
    • Celaya, Guanajuato, Mexico, 38000
      • Novartis Investigative Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Novartis Investigative Site
    • Guadalajara, Jalisco, Mexico, 44150
      • Novartis Investigative Site
    • Guadalajara, Jalisco, Mexico, 44600
      • Novartis Investigative Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64710
      • Novartis Investigative Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64020
      • Novartis Investigative Site
  • Quintana Roo
    • Cancun, Quintana Roo, Mexico, 77500
      • Novartis Investigative Site
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Informed consent read and signed before any protocol procedure.
2. Free will to sign the informed consent.
3. 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.
4. Type 2 diabetes mellitus
5. 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.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.

Exclusion Criteria

1. Pregnant or lactating female or without birth control method if of childbearing potential.
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years

Other inlcusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetes,; insulin,; Diabetes,; Diabetes mellitus,
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Vildagliptin
• Other Study ID Numbers: CLAF237AMX01