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

Primary Purpose

Type 2 Diabetes, Hypoglycemia

Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
vildagliptin and metformin (combination)
glimepiride
Metformin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, hypoglycemia, glycemic variability, vildagliptin, glimepiride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

vildagliptin and metformin

glimepiride and metformin

Arm Description

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

Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Outcomes

Primary Outcome Measures

Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)
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)
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)
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
Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline
Number of Patients With Incidence of Hypoglycemia
Hypoglycemia defined as Glycemia < 70 mg/dl
Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment
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

Full Information

First Posted
December 5, 2013
Last Updated
April 13, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02007278
Brief Title
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
Acronym
GLOBE
Official Title
Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2014 (Actual)
Primary Completion Date
February 22, 2016 (Actual)
Study Completion Date
February 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Hypoglycemia
Keywords
diabetes, hypoglycemia, glycemic variability, vildagliptin, glimepiride

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vildagliptin and metformin
Arm Type
Active Comparator
Arm Description
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
Arm Title
glimepiride and metformin
Arm Type
Active Comparator
Arm Description
Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
Intervention Type
Drug
Intervention Name(s)
vildagliptin and metformin (combination)
Intervention Description
vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)
Description
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.
Time Frame
Week 12
Title
Glycemic Variability Measured by Total Standard Deviation (TSD)
Description
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.
Time Frame
Week 12
Title
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
Title
Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline
Time Frame
baseline, 12 weeks of treatment
Title
Number of Patients With Incidence of Hypoglycemia
Description
Hypoglycemia defined as Glycemia < 70 mg/dl
Time Frame
12 weeks
Title
Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment
Description
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.
Time Frame
12 weeks
Title
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Medellín
State/Province
Antioquia
Country
Colombia
Facility Name
Novartis Investigative Site
City
Manizales
State/Province
Caldas
ZIP/Postal Code
1700
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Chía
State/Province
Cundinamarca
ZIP/Postal Code
11001000
Country
Colombia
Facility Name
Novartis Investigative Site
City
Cali
State/Province
Valle del Cauca
ZIP/Postal Code
760001
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Novartis Investigative Site
City
Cali
Country
Colombia
Facility Name
Novartis Investigative Site
City
Monteria
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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