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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Hypoglycemia
Intervention	Drug: vildagliptin and metformin (combination) Drug: glimepiride Drug: Metformin
Phase	Phase 4
Sponsor	Novartis Pharmaceuticals
Responsible Party	Novartis
ClinicalTrials.gov Identifier	NCT02007278
First Received	December 5, 2013
Last Updated	March 25, 2014
Last verified	March 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 5, 2013
Last Updated Date	March 25, 2014
Start Date	January 2014
Estimated Primary Completion Date	October 2014
Current Primary Outcome Measures	glycemic variability measured by Mean Amplitude of Average Glucose Excursions (MAGE) [Time Frame: 12 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	glycemic variability measured by Continuous Overlapping Net Glycemic Action (CONGA) [Time Frame: 12 weeks] [Designated as safety issue: No]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. 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 [Time Frame: Screening visit , 12 weeks of treatment] [Designated as safety issue: No] Percentage of reduction achieved in the mean HbA1c at week 12 of treatment in comparison to HbA1c at screening visit [Time Frame: Screening visit , 12 weeks of treatment] [Designated as safety issue: No] Degree of correlation between MAGE value and hypoglycemia incidence [Time Frame: 12 weeks] [Designated as safety issue: No] percentage of patients with incidence of hypoglycemia [Time Frame: 12 weeks] [Designated as safety issue: Yes]Hypoglycemia defined as Glycemia < 70 mg/dl Glycemic variability measured by Total Standard Deviation (TSD) [Time Frame: 12 weeks] [Designated as safety issue: No]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. Number of patients with adverse events, serious adverse events and death [Time Frame: 12 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Official Title	Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Hypoglycemia
Intervention	Drug: vildagliptin and metformin (combination) vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid Drug: glimepiride Drug: Metformin
Study Arm (s)	Active Comparator: vildagliptin and metformin 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 Active Comparator: glimepiride and metformin Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	40
Estimated Completion Date	October 2014
Estimated Primary Completion Date	October 2014
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Novartis Pharmaceuticals +41613241111
Location Countries	Colombia

Administrative Information[ + expand ][ + ]

NCT Number	NCT02007278
Other Study ID Numbers	CLAF237ACO01
Has Data Monitoring Committee	No
Information Provided By	Novartis
Study Sponsor	Novartis Pharmaceuticals
Collaborators	Not Provided
Investigators	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification Date	March 2014

Locations[ + expand ][ + ]

Novartis Investigative Site	Medellín, Antioquia, Colombia Not yet recruiting
Novartis Investigative Site	Manizales, Caldas, Colombia, 1700 Recruiting
Novartis Investigative Site	Manizales, Caldas, Colombia, 1700 Not yet recruiting
Novartis Investigative Site	Bogotá, Cundinamarca, Colombia Not yet recruiting
Novartis Investigative Site	Chía, Cundinamarca, Colombia, 11001000 Not yet recruiting
Novartis Investigative Site	Cali, Valle del Cauca, Colombia, 001 Recruiting