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Name: 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.
Creator: Novartis Pharmaceuticals
Published: 2013-05-24
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT01862263 (VIDA) for Type 2 Diabetes Mellitus is terminated. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes (VIDA) Phase 4 191

Terminated

Clinical Trial NCT01862263 (VIDA) is designed to study Treatment for Type 2 Diabetes Mellitus. It is a Phase 4 interventional study that is terminated, having started on 1 May 2013, with plans to enroll 191 participants. Led by Novartis Pharmaceuticals, it is expected to complete by 1 July 2015. The latest data from ClinicalTrials.gov was last updated on 5 June 2019.

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.

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.

Conditions

Type 2 Diabetes Mellitus

Other Study IDs

VIDA
CLAF237AMX01

NCT ID Number

NCT01862263

Start Date (Actual)

2013-05

Last Update Posted

2019-06-05

Completion Date (Estimated)

2015-07

Enrollment (Estimated)

191

Study Type

Interventional

PHASE

Phase 4

Status

Terminated

Keywords

Diabetes,
Type 2 diabetes,
Diabetes mellitus,
insulin,

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Double

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalVildagliptin Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day	Vildagliptin Orally active and highly selective inhibitor of DPP-4 Insulin Long- acting human insulin analog indicated to improve glycemic control
Placebo ComparatorPlacebo Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)	Insulin Long- acting human insulin analog indicated to improve glycemic control 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

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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.

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

Novartis Pharmaceuticals

No contact data.

13 Study Locations in 1 Countries

Mexico

Guanajuato

Novartis Investigative Site, Celaya, Guanajuato, 38000, Mexico

Jalisco

Novartis Investigative Site, Guadalajara, Jalisco, 44150, Mexico

Novartis Investigative Site, Guadalajara, Jalisco, 44600, Mexico

Novartis Investigative Site, Guadalajara, Jalisco, 44670, Mexico

Mexico City

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

Nuevo León

Novartis Investigative Site, Monterrey, Nuevo León, 64020, Mexico

Novartis Investigative Site, Monterrey, Nuevo León, 64710, Mexico

Quintana Roo

Novartis Investigative Site, Cancún, Quintana Roo, 77500, Mexico

Sinaloa

Novartis Investigative Site, Culiacán, Sinaloa, 80000, Mexico

State of Mexico

Novartis Investigative Site, Metepec, State of Mexico, 52140, Mexico

Novartis Investigative Site, Puebla City, 72190, Mexico

Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes (VIDA) Phase 4 191

Inclusion Criteria

Exclusion Criteria