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

Phase 4

Completed

• Conditions: Hypoglycemia; Type 2 Diabetes
• Interventions: Drug: vildagliptin and metformin (combination); Drug: glimepiride; Drug: Metformin

• Registration Number: NCT02007278
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Study Start: 2014-01-03
• Primary Completion: 2016-02-22
• Study Completion: 2016-02-22
• Results First Submitted: 2017-02-23
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vildagliptin and metformin	vildagliptin and metformin (combination)	Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks
glimepiride and metformin	glimepiride	Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
glimepiride and metformin	Metformin	Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Primary Outcome Measures

Name	Time	Method
Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)	Week 12	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.
Glycemic Variability Measured by Total Standard Deviation (TSD)	Week 12	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.
Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12	Screening visit , 12 weeks of treatment
Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline	baseline, 12 weeks of treatment
Number of Patients With Incidence of Hypoglycemia	12 weeks	Hypoglycemia defined as Glycemia \< 70 mg/dl
Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment	12 weeks	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. In this endpoint, mean MAGE value is reported for hypo glycemic patients.
Number of Patients With Any Adverse Events, Serious Adverse Events and Death	12 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇴 Monteria, Colombia