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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02007278
First Posted: December 10, 2013
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

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
Intervention Model: Parallel Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) [ Time Frame: 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:
  • Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Screening visit , 12 weeks of treatment ]
  • Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline [ Time Frame: baseline, 12 weeks of treatment ]
  • Number of Patients With Incidence of Hypoglycemia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks ]

Enrollment: 40
Actual Study Start Date: January 3, 2014
Study Completion Date: February 22, 2016
Primary Completion Date: February 22, 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007278


Locations
Colombia
Novartis Investigative Site
Medellín, Antioquia, Colombia
Novartis Investigative Site
Manizales, Caldas, Colombia, 1700
Novartis Investigative Site
Bogotá, Cundinamarca, Colombia
Novartis Investigative Site
Chía, Cundinamarca, Colombia, 11001000
Novartis Investigative Site
Cali, Valle del Cauca, Colombia, 760001
Novartis Investigative Site
Bogotá, Colombia, 00000
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Monteria, Colombia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02007278     History of Changes
Other Study ID Numbers: CLAF237ACO01
First Submitted: December 5, 2013
First Posted: December 10, 2013
Results First Submitted: February 23, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
diabetes
hypoglycemia
glycemic variability
vildagliptin
glimepiride

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action