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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02007278
First received: December 5, 2013
Last updated: March 25, 2014
Last verified: March 2014
  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 Intervention Phase
Type 2 Diabetes
Hypoglycemia
Drug: vildagliptin and metformin (combination)
Drug: glimepiride
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin

Resource links provided by NLM:


Further study details as provided by Novartis:

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.


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 ]

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: vildagliptin and metformin (combination)
vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
Active Comparator: glimepiride and metformin
Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
Drug: glimepiride Drug: Metformin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007278

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Colombia
Novartis Investigative Site Not yet recruiting
Medellín, Antioquia, Colombia
Novartis Investigative Site Recruiting
Manizales, Caldas, Colombia, 1700
Novartis Investigative Site Not yet recruiting
Manizales, Caldas, Colombia, 1700
Novartis Investigative Site Not yet recruiting
Bogotá, Cundinamarca, Colombia
Novartis Investigative Site Not yet recruiting
Chía, Cundinamarca, Colombia, 11001000
Novartis Investigative Site Recruiting
Cali, Valle del Cauca, Colombia, 001
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02007278     History of Changes
Other Study ID Numbers: CLAF237ACO01
Study First Received: December 5, 2013
Last Updated: March 25, 2014
Health Authority: National Institute of Food and Drug Monitoring (INVIMA): Colombia

Keywords provided by Novartis:
diabetes
hypoglycemia
glycemic variability
vildagliptin
glimepiride

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014