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

June 3, 2019 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with hyperglycemic events evaluated with CGM
Time Frame: 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.
At 13 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of hypoglycemia and/or hyperglycemia measured by CGM
Time Frame: 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.
13 weeks
Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day
Time Frame: 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
0 to 24 hours daily for week 1, 4 and 13
Average of insulin units per day administered during the study
Time Frame: 13 weeks
Change from baseline
13 weeks
Changes from the baseline in Lipid Profile
Time Frame: Baseline, 13 weeks
Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
Baseline, 13 weeks
Change from baseline in Body weight
Time Frame: Baseline, 13 weeks
Weight will be measured on Kg.
Baseline, 13 weeks
Change from baseline in Blood pressure (BP),
Time Frame: Baseline, 13 weeks
BP will be mesured on mmHg
Baseline, 13 weeks
Change from baseline in Fasting plasma glucose (FPG),
Time Frame: Baseline, 13 weeks
FPG will be measured on mg/dL
Baseline, 13 weeks
Change from baseline in Hemoglobin A1C (HbA1c)
Time Frame: Baseline, 13 weeks
HbA1c will be measured on %
Baseline, 13 weeks
Change from baseline in Creatinine
Time Frame: Baseline, 13 weeks
Creatinine will be measured on mg/dL
Baseline, 13 weeks
Change from baseline in C-peptide
Time Frame: Baseline, 13 weeks
C-Peptide will be measured on microIU/mL
Baseline, 13 weeks
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
Time Frame: Baseline, 13 week
ALT/AST will be measured on ratio.
Baseline, 13 week
Changes from baseline in Direct bilirubin
Time Frame: Baseline, 13 weeks
Bilirubin will be measure on mg/dL
Baseline, 13 weeks
Changes from baseline in Body Mass Index (BMI)
Time Frame: Baseline, 13 weeks
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
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLAF237AMX01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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