Trial · NCT02007278
Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
NCT02007278, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2017-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride. Trials, record NCT02007278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02007278
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride
- NCT number
- NCT02007278
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Type 2 Diabetes, Hypoglycemia
- Interventions
- vildagliptin and metformin (combination), glimepiride, Metformin
- First posted
- 2013-12-10
- Last updated
- 2017-07-11
- Results first posted
- 2017-07-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) | 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 | Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) | 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. |
| Secondary | Glycemic Variability Measured by Total Standard Deviation (TSD) | 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. |
| Secondary | Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12 | Screening visit , 12 weeks of treatment | |
| Secondary | Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline | baseline, 12 weeks of treatment | |
| Secondary | Number of Patients With Incidence of Hypoglycemia | 12 weeks | Hypoglycemia defined as Glycemia \< 70 mg/dl |
| Secondary | Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment | 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. |
| Secondary | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 12 weeks |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) | Week 12 | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison. | mg/dL | MEAN |
| SECONDARY | Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) | Week 12 | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison. | mg/dL | MEAN |
| SECONDARY | Glycemic Variability Measured by Total Standard Deviation (TSD) | Week 12 | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison. | mg/dL | MEAN |
| SECONDARY | Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12 | Screening visit , 12 weeks of treatment | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data | percentage of patients | NUMBER |
| SECONDARY | Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline | baseline, 12 weeks of treatment | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data | Percentage of glycosylated haemoglobin | MEAN |
| SECONDARY | Number of Patients With Incidence of Hypoglycemia | 12 weeks | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison. | Patients | NUMBER |
| SECONDARY | Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment | 12 weeks | Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison and had at least one hypoglycemia event. | mg/dL | MEAN |
| SECONDARY | Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 12 weeks | All the randomized patients. | Patients | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) | Vildagliptin and Metformin | 6.68 | Standard Deviation 1.48 | mg/dL | |
| Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE) | Glimepiride and Metformin | 6.23 | Standard Deviation 1.08 | mg/dL | |
| Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) | Vildagliptin and Metformin | 2.92 | Standard Deviation 0.93 | mg/dL | |
| Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA) | Glimepiride and Metformin | 3.01 | Standard Deviation 1.10 | mg/dL | |
| Glycemic Variability Measured by Total Standard Deviation (TSD) | Vildagliptin and Metformin | 1.36 | Standard Deviation 0.40 | mg/dL | |
| Glycemic Variability Measured by Total Standard Deviation (TSD) | Glimepiride and Metformin | 1.40 | Standard Deviation 0.42 | mg/dL | |
| Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12 | Vildagliptin and Metformin | 100.0 | percentage of patients | ||
| Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12 | Glimepiride and Metformin | 100.0 | percentage of patients | ||
| Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline | Vildagliptin and Metformin | 1.92 | Standard Deviation 1.1 | Percentage of glycosylated haemoglobin | |
| Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline | Glimepiride and Metformin | 2.28 | Standard Deviation 0.79 | Percentage of glycosylated haemoglobin |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vildagliptin and Metformin | 20 | |
| Overall Study | STARTED | Glimepiride and Metformin | 20 | |
| Overall Study | COMPLETED | Vildagliptin and Metformin | 18 | |
| Overall Study | COMPLETED | Glimepiride and Metformin | 17 | |
| Overall Study | NOT COMPLETED | Vildagliptin and Metformin | 2 | |
| Overall Study | NOT COMPLETED | Glimepiride and Metformin | 3 |
Source ClinicalTrials.gov
Adverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Vildagliptin and Metformin | 0 | 20 | |
| other | Palpitations | Cardiac disorders | Glimepiride and Metformin | 1 | 20 | |
| other | Ear pain | Ear and labyrinth disorders | Vildagliptin and Metformin | 1 | 20 | |
| other | Ear pain | Ear and labyrinth disorders | Glimepiride and Metformin | 0 | 20 | |
| other | Vertigo | Ear and labyrinth disorders | Vildagliptin and Metformin | 1 | 20 | |
| other | Vertigo | Ear and labyrinth disorders | Glimepiride and Metformin | 0 | 20 | |
| other | Cataract | Eye disorders | Vildagliptin and Metformin | 0 | 20 | |
| other | Cataract | Eye disorders | Glimepiride and Metformin | 1 | 20 | |
| other | Eye irritation | Eye disorders | Vildagliptin and Metformin | 1 | 20 | |
| other | Eye irritation | Eye disorders | Glimepiride and Metformin | 0 | 20 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vildagliptin and Metformin | ||
| Total, all-cause mortality | Glimepiride and Metformin | ||
| Total, other adverse events | Vildagliptin and Metformin | 9 | 20 |
| Total, other adverse events | Glimepiride and Metformin | 13 | 20 |
| Total, serious adverse events | Vildagliptin and Metformin | 0 | 20 |
| Total, serious adverse events | Glimepiride and Metformin | 1 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vildagliptin and Metformin vs Glimepiride and Metformin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02007278
GET https://conductscience.org/api/trials/v1/NCT02007278/events?page=2