Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride

Phase 4CompletedNCT02007278

Novartis Pharmaceuticals40 enrolled

Overview

The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Hypoglycemia

Interventions

vildagliptin and metformin (combination)DRUG

vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid

glimepirideDRUG

MetforminDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * HbA1c between 8%-10.5% in stable metformin dose (\>1500 mg/day), four weeks prior visit 1 Key Exclusion Criteria: * Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin

Locations (8)

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Manizales, Caldas Department, Colombia

Novartis Investigative Site

Cali, Colombia, Colombia

Novartis Investigative Site

Bogotá, Cundinamarca, Colombia

Outcomes

Primary Outcomes

Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)

Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ\> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.

Time frame: Week 12

Secondary Outcomes

Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)

Continuous Overlapping Net Glycemic Action (CONGA) which assesses intra-day glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible. CONGA is calculated in the conventional way with the formula √tқΣt = t1 (Dt -Ď2) / қ - 1, Ď = tқ Σ Dt t = t1 / қ, Dt = Gt-Gt-m (where қ = Observations with an observation n x 60 minutes, G = glucose measure) from the data of continuous monitoring of tissue glucose obtained during the measurement period.

Time frame: Week 12

Glycemic Variability Measured by Total Standard Deviation (TSD)

Total standard deviation (TSD) or standard deviation of all values of a given measurement period, which has the advantage of being able to include all measured values on a given time period (even several days) through a common and simple statistical concept. TSD is calculated conventionally with the formula σ = √Σ (Xi - ῦ) 2 / N (where Xi represents each of the values, ῦ represents the population mean and N is the number of observations) from the data of continuous monitoring of tissue glucose obtained during the measurement.

Time frame: Week 12

Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12

Data from ClinicalTrials.gov

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