Trial · NCT01822548
Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes
NCT01822548, Phase 3, Completed, Azienda Ospedaliero-Universitaria di Parma; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes. Trials, record NCT01822548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01822548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes
- NCT number
- NCT01822548
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Conditions
- Type 2 Diabetes
- Interventions
- Vildagliptin, Glibenclamide, Metformin
- First posted
- 2013-04-02
- Last updated
- 2017-08-02
- Results first posted
- 2017-08-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in the Endothelial Progenitor Cell (EPC) Number | V0, V2 (month 4), V4 (12 month) | The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months. |
| Secondary | Absolute Change in HbA1C Compared to Baseline | V0 (randomization), V2 (month4), V4 (month 12). | The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in the Endothelial Progenitor Cell (EPC) Number | V0, V2 (month 4), V4 (12 month) | Intention to treat (ITT) analysis | EPC/10^6 cells | MEDIAN |
| SECONDARY | Absolute Change in HbA1C Compared to Baseline | V0 (randomization), V2 (month4), V4 (month 12). | percentage | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in the Endothelial Progenitor Cell (EPC) Number | Vildagliptin & Metformin | V2 (4 month) | 37 | Inter-Quartile Range 27.0 to 65.0 | EPC/10^6 cells |
| Absolute Change in the Endothelial Progenitor Cell (EPC) Number | Glibenclamide & Metformin | V2 (4 month) | 36 | Inter-Quartile Range 23.0 to 54.2 | EPC/10^6 cells |
| Absolute Change in the Endothelial Progenitor Cell (EPC) Number | Vildagliptin & Metformin | V4 (12 month) | 45 | Inter-Quartile Range 29.7 to 67 | EPC/10^6 cells |
| Absolute Change in the Endothelial Progenitor Cell (EPC) Number | Glibenclamide & Metformin | V4 (12 month) | 32 | Inter-Quartile Range 22.2 to 53.5 | EPC/10^6 cells |
| Absolute Change in HbA1C Compared to Baseline | Vildagliptin & Metformin | V2 (4 month) | 6.8 | Inter-Quartile Range 6.4 to 7.3 | percentage |
| Absolute Change in HbA1C Compared to Baseline | Glibenclamide & Metformin | V2 (4 month) | 6.8 | Inter-Quartile Range 6.4 to 7.3 | percentage |
| Absolute Change in HbA1C Compared to Baseline | Vildagliptin & Metformin | V4 (12 month) | 7.0 | Inter-Quartile Range 6.5 to 7.3 | percentage |
| Absolute Change in HbA1C Compared to Baseline | Glibenclamide & Metformin | V4 (12 month) | 7.1 | Inter-Quartile Range 6.5 to 7.5 | percentage |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vildagliptin & Metformin | 40 | |
| Overall Study | STARTED | Glibenclamide & Metformin | 24 | |
| Overall Study | Discontinued Intervention | Vildagliptin & Metformin | 0 | |
| Overall Study | Discontinued Intervention | Glibenclamide & Metformin | 5 | |
| Overall Study | COMPLETED | Vildagliptin & Metformin | 40 | |
| Overall Study | COMPLETED | Glibenclamide & Metformin | 24 | |
| Overall Study | NOT COMPLETED | Vildagliptin & Metformin | 0 | |
| Overall Study | NOT COMPLETED | Glibenclamide & Metformin | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | hypoglycemia | Metabolism and nutrition disorders | Vildagliptin & Metformin | 0 | 40 | 0 |
| other | hypoglycemia | Metabolism and nutrition disorders | Glibenclamide & Metformin | 5 | 24 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vildagliptin & Metformin | ||
| Total, all-cause mortality | Glibenclamide & Metformin | ||
| Total, other adverse events | Vildagliptin & Metformin | 0 | 40 |
| Total, other adverse events | Glibenclamide & Metformin | 5 | 24 |
| Total, serious adverse events | Vildagliptin & Metformin | 0 | 40 |
| Total, serious adverse events | Glibenclamide & Metformin | 0 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28231835 | DERIVED |
Source PubMed
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 & Metformin vs Glibenclamide & 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/NCT01822548
GET https://conductscience.org/api/trials/v1/NCT01822548/registered