Glycemic Holter Study (Continuous Glucose Monitoring) -

Phase 4CompletedNCT01193296

Novartis36 enrolled

Overview

The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

VildagliptinDRUG

SitagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions. * HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months Exclusion Criteria: * Age \>= 80 years * BMI \<= 22 and \>=40 kg/m2 * Secondary T2 DM * Hepatic failure, ASAT/ALAT\>3 ULN, and moderate/severe renal failure (CI \< 50 ml/min) CHF III \& IV Other protocol-defined inclusion/exclusion criteria may apply

Locations (7)

Investigative Site

Bondy, France

Investigative Site

Corbeil, France

Investigative Site

Marseille, France

Investigative Site

Nancy, France

Outcomes

Primary Outcomes

Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)

Time frame: 8 weeks

Secondary Outcomes

Glycemic control assessed through CSGM

Time frame: 8 weeks

Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks

Time frame: 8 weeks

Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration

Time frame: 8 weeks

Data from ClinicalTrials.gov

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