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

NCT01862263 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2019-06-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vildagliptin

Orally active and highly selective inhibitor of DPP-4

DRUG

Insulin

Long- acting human insulin analog indicated to improve glycemic control

DRUG

Placebo

Matching placebo of vildagliptin

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862263 on ClinicalTrials.gov