Trial · NCT01910441
Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
NCT01910441, Phase 4, Terminated, Novartis Pharmaceuticals; results first posted 2015-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients. Trials, record NCT01910441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01910441
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
- NCT number
- NCT01910441
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 95 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Vildagliptin, Glimepiride, Metformin
- First posted
- 2013-07-29
- Last updated
- 2015-10-28
- Results first posted
- 2015-10-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Amplitude of Glycemic Excursions (MAGE) | 16 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Amplitude of Glycemic Excursions (MAGE) | 16 weeks | The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Vildagliptin Plus Metformin | 48 | |
| Overall Study | STARTED | Group B: Glimepiride Plus Metformin | 47 | |
| Overall Study | COMPLETED | Group A: Vildagliptin Plus Metformin | 41 | |
| Overall Study | COMPLETED | Group B: Glimepiride Plus Metformin | 37 | |
| Overall Study | NOT COMPLETED | Group A: Vildagliptin Plus Metformin | 7 | |
| Overall Study | NOT COMPLETED | Group B: Glimepiride Plus Metformin | 10 |
Source ClinicalTrials.gov
Adverse events8
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 | DIABETES MELLITUS | Metabolism and nutrition disorders | Group A: Vildagliptin Plus Metformin | 4 | 48 | |
| other | DIABETES MELLITUS | Metabolism and nutrition disorders | Group B: Glimepiride Plus Metformin | 1 | 47 | |
| serious | HEADACHE | Nervous system disorders | Group A: Vildagliptin Plus Metformin | 0 | 48 | |
| serious | HEADACHE | Nervous system disorders | Group B: Glimepiride Plus Metformin | 1 | 47 | |
| serious | RESTLESSNESS | Psychiatric disorders | Group A: Vildagliptin Plus Metformin | 0 | 48 | |
| serious | RESTLESSNESS | Psychiatric disorders | Group B: Glimepiride Plus Metformin | 1 | 47 | |
| serious | HYPERHIDROSIS | Skin and subcutaneous tissue disorders | Group A: Vildagliptin Plus Metformin | 0 | 48 | |
| serious | HYPERHIDROSIS | Skin and subcutaneous tissue disorders | Group B: Glimepiride Plus Metformin | 1 | 47 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Vildagliptin Plus Metformin | ||
| Total, all-cause mortality | Group B: Glimepiride Plus Metformin | ||
| Total, other adverse events | Group A: Vildagliptin Plus Metformin | 4 | 48 |
| Total, other adverse events | Group B: Glimepiride Plus Metformin | 1 | 47 |
| Total, serious adverse events | Group A: Vildagliptin Plus Metformin | 0 | 48 |
| Total, serious adverse events | Group B: Glimepiride Plus Metformin | 1 | 47 |
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 |
|---|
| Group A: Vildagliptin Plus Metformin vs Group B: Glimepiride Plus 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/NCT01910441
GET https://conductscience.org/api/trials/v1/NCT01910441/registered