Type 2 DiabetesPhase 4GLOBENCT02007278
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
A Phase 4 study testing vildagliptin and metformin (combination), glimepiride and Metformin in people with Type 2 Diabetes and Hypoglycemia, run by Novartis Pharmaceuticals at 8 sites in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hypoglycemia
- What is being tested?
- vildagliptin and metformin (combination), glimepiride and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesColombia
- Study dates
- 3 Jan 2014to 22 Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1
Who cannot join
- Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Colombia8 sites
Novartis Investigative Site
Bogotá, Cundinamarca
Novartis Investigative Site
Bogotá, 00000
Novartis Investigative Site
Cali, Colombia
Novartis Investigative Site
Cali, Valle del Cauca Department, 760001
Novartis Investigative Site
Chía, Cundinamarca, 11001000
Novartis Investigative Site
Manizales, Caldas Department, 1700
Novartis Investigative Site
Medellín, Antioquia
Novartis Investigative Site
Montería
About this study
Official title: Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
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.
- Conditions
- Type 2 Diabetes, Hypoglycemia
- Being tested
- vildagliptin and metformin (combination), glimepiride, Metformin
- Keywords
- diabetes, hypoglycemia, glycemic variability, vildagliptin, glimepiride
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptin and metformin (combination)Drug
vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
glimepirideDrug
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin and metformin | Active comparator | 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 Receives: Drug: vildagliptin and metformin (combination) |
| glimepiride and metformin | Active comparator | Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin Receives: Drug: glimepiride; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (7)
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.
Measured: Week 12
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.
Measured: Week 12
Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12
Measured: Screening visit , 12 weeks of treatment
Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline
Measured: baseline, 12 weeks of treatment
Number of Patients With Incidence of Hypoglycemia
Hypoglycemia defined as Glycemia < 70 mg/dl
Measured: 12 weeks
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.
Measured: 12 weeks
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study start3 Jan 2014
- Primary completion22 Feb 2016
- Study completion22 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007278
- Sponsor's protocol ID
- CLAF237ACO01
- Acronym
- GLOBE
- Status last verified
- Apr 2017
- First submitted
- 5 Dec 2013
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Excursions in Type 2 Diabetic Patients Treated With Vildagliptin and Metformin (GalvusMet) Versus Glimepiride and Metformin
- ClinicalTrials.gov ID
- NCT02007278
- Acronym / sponsor ID
- GLOBE / CLAF237ACO01
- Conditions
- Type 2 Diabetes, Hypoglycemia
- Keywords
- diabetes, hypoglycemia, glycemic variability, vildagliptin, glimepiride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2014 (actual)
- Primary completion
- 22 Feb 2016 (actual)
- Study completion
- 22 Feb 2016 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vildagliptin and metformin | Active comparator | Drug: vildagliptin and metformin (combination)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 |
| glimepiride and metformin | Active comparator | Drug: glimepiride, Drug: MetforminProtocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1
Key exclusion criteria (1 listed)
- Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vildagliptin and metformin (combination)vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid | Drug | vildagliptin and metformin |
| glimepiride | Drug | glimepiride and metformin |
| Metformin | Drug | glimepiride and metformin |
Primary outcome
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.
7 secondary outcomes
Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)
Time frame: Week 12
Glycemic Variability Measured by Total Standard Deviation (TSD)
Time frame: Week 12
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
Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment
Time frame: 12 weeks
Number of Patients With Any Adverse Events, Serious Adverse Events and Death
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vildagliptin and metformin (combination), glimepiride and Metformin in people with Type 2 Diabetes and Hypoglycemia, run by Novartis Pharmaceuticals at 8 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.