Trial · NCT02280486
Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
NCT02280486, Phase 4, Completed, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin. Trials, record NCT02280486. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02280486
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
- NCT number
- NCT02280486
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 388 participants, actual
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Conditions
- Type 2 Diabetes
- Interventions
- Saxagliptin, Glimepiride
- First posted
- 2014-10-31
- Last updated
- 2018-07-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0% | Change from Baseline after 48 weeks treatment | Compare the proportion of subjects after 48-week treatment achieving HbA1c\<7.0%, with no hypoglycemia and no body weight gain (defined as glucose \< 3.9 mmol/L with or without symptoms and weight gain \< 3.0%). |
| Secondary | The change in blood glucose fluctuations of subjects. | Change from Baseline after 48 weeks treatment | 30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment. |
| Secondary | The improvement in beta-cell function of subjects | Change from Baseline after 48 weeks treatment | All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment. |
| Secondary | The change in body composition of subjects. | Change from Baseline after 48 weeks treatment | All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 48 weeks treatment. |
| Secondary | Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests | Change from Baseline after 48 weeks treatment | The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose \< 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30520221 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02280486
GET https://conductscience.org/api/trials/v1/NCT02280486/registered