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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Vildagliptin
Insulin
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes,, Type 2 diabetes,, Diabetes mellitus,, insulin,

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day

Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Average of insulin units per day administered during the study
Change from baseline
Changes from the baseline in Lipid Profile
Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
Change from baseline in Body weight
Weight will be measured on Kg.
Change from baseline in Blood pressure (BP),
BP will be mesured on mmHg
Change from baseline in Fasting plasma glucose (FPG),
FPG will be measured on mg/dL
Change from baseline in Hemoglobin A1C (HbA1c)
HbA1c will be measured on %
Change from baseline in Creatinine
Creatinine will be measured on mg/dL
Change from baseline in C-peptide
C-Peptide will be measured on microIU/mL
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
ALT/AST will be measured on ratio.
Changes from baseline in Direct bilirubin
Bilirubin will be measure on mg/dL
Changes from baseline in Body Mass Index (BMI)
Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin

Full Information

First Posted
May 22, 2013
Last Updated
June 3, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01862263
Brief Title
Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
Acronym
VIDA
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes,, Type 2 diabetes,, Diabetes mellitus,, insulin,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Description
Orally active and highly selective inhibitor of DPP-4
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Long- acting human insulin analog indicated to improve glycemic control
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo of vildagliptin
Primary Outcome Measure Information:
Title
Percentage of patients with hyperglycemic events evaluated with CGM
Description
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.
Time Frame
At 13 weeks
Secondary Outcome Measure Information:
Title
Number of hypoglycemia and/or hyperglycemia measured by CGM
Description
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.
Time Frame
13 weeks
Title
Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day
Description
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
Time Frame
0 to 24 hours daily for week 1, 4 and 13
Title
Average of insulin units per day administered during the study
Description
Change from baseline
Time Frame
13 weeks
Title
Changes from the baseline in Lipid Profile
Description
Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
Time Frame
Baseline, 13 weeks
Title
Change from baseline in Body weight
Description
Weight will be measured on Kg.
Time Frame
Baseline, 13 weeks
Title
Change from baseline in Blood pressure (BP),
Description
BP will be mesured on mmHg
Time Frame
Baseline, 13 weeks
Title
Change from baseline in Fasting plasma glucose (FPG),
Description
FPG will be measured on mg/dL
Time Frame
Baseline, 13 weeks
Title
Change from baseline in Hemoglobin A1C (HbA1c)
Description
HbA1c will be measured on %
Time Frame
Baseline, 13 weeks
Title
Change from baseline in Creatinine
Description
Creatinine will be measured on mg/dL
Time Frame
Baseline, 13 weeks
Title
Change from baseline in C-peptide
Description
C-Peptide will be measured on microIU/mL
Time Frame
Baseline, 13 weeks
Title
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
Description
ALT/AST will be measured on ratio.
Time Frame
Baseline, 13 week
Title
Changes from baseline in Direct bilirubin
Description
Bilirubin will be measure on mg/dL
Time Frame
Baseline, 13 weeks
Title
Changes from baseline in Body Mass Index (BMI)
Time Frame
Baseline, 13 weeks
Title
Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent read and signed before any protocol procedure. Free will to sign the informed consent. 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. Type 2 diabetes mellitus 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. HbA1c between 7.5 to 9%. Fasting plasma glucose (FPG) less than 270 mg/dL. Body mass index (BMI) between 20 to 35 kg/m2. Free willing to take the vildagliptin tablets during the study. Exclusion Criteria Pregnant or lactating female or without birth control method if of childbearing potential. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome. Acute cardiovascular complications or metabolic complications within the past 4 months. History cerebrovascular disease during the last year. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery). Congestive heart failure requiring pharmacologic treatment. Any known serious heart condition. ALT and/or AST greater than three times the upper limit of the normal range. Serum creatinine levels greater than 1.5 mg/dL Malignancy including leukemia and lymphoma within the last 5 years Other inlcusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07300
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Novartis Investigative Site
City
Metepec
State/Province
Estado De México
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Novartis Investigative Site
City
Celaya
State/Province
Guanajuato
ZIP/Postal Code
38000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Novartis Investigative Site
City
Cancun
State/Province
Quintana Roo
ZIP/Postal Code
77500
Country
Mexico
Facility Name
Novartis Investigative Site
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Puebla
ZIP/Postal Code
72190
Country
Mexico

12. IPD Sharing Statement

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

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