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

Type 2 Diabetes Clinical Trial

— GLOBE  

Official title:

Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007278
• Other study ID #: CLAF237ACO01
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2013
• Last updated: May 4, 2016
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: National Institute of Food and Drug Monitoring (INVIMA): Colombia
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1

Exclusion Criteria:

• Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia
• Type 2 Diabetes

Intervention

Drug:
• vildagliptin and metformin (combination)
vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
• glimepiride

• Metformin

Locations

Country	Name	City	State
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Cali
Colombia	Novartis Investigative Site	Cali	Valle del Cauca
Colombia	Novartis Investigative Site	Chía	Cundinamarca
Colombia	Novartis Investigative Site	Manizales	Caldas
Colombia	Novartis Investigative Site	Medellín	Antioquia
Colombia	Novartis Investigative Site	Monteria

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic variability measured by Mean Amplitude of Average Glucose Excursions (MAGE)	Mean Amplitude of Glycemic Excursions (MAGE) , which determine 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.	12 weeks	No
Secondary	glycemic variability measured by Continuous Overlapping Net Glycemic Action (CONGA)	Continuous Overlapping Net Glycemic Action (CONGA) which assesses intraday glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible.	12 weeks	No
Secondary	Percentage of patients who achieve a decrease equal to or greater than 0.3% in value of HbA1c at week 12 of treatment in comparison to HbA1c value at screening visit		Screening visit , 12 weeks of treatment	No
Secondary	Percentage of reduction achieved in the mean HbA1c at week 12 of treatment in comparison to HbA1c at screening visit		Screening visit , 12 weeks of treatment	No
Secondary	Degree of correlation between MAGE value and hypoglycemia incidence		12 weeks	No
Secondary	percentage of patients with incidence of hypoglycemia	Hypoglycemia defined as Glycemia < 70 mg/dl	12 weeks	Yes
Secondary	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.	12 weeks	No
Secondary	Number of patients with adverse events, serious adverse events and death		12 weeks	Yes