Trial · NCT06863532
Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
NCT06863532, Not applicable, Recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial. Trials, record NCT06863532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06863532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
- NCT number
- NCT06863532
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Type 2 Diabetes
- Interventions
- Cofrogliptin+SGLT2i+Metformin, Metformin dose escalation
- First posted
- 2025-03-07
- Last updated
- 2025-03-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the change in glycated hemoglobin (HbA1c) levels | throughout the study, about 1 year | the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therap |
| Secondary | The proportion of subjects with HbA1c < 7.0% and < 6.5% | throughout the study, about 1 year | The proportion of subjects with HbA1c \< 7.0% and \< 6.5% after 24 weeks of treatment. |
| Secondary | 2h-PPG and FPG | throughout the study, about 1 year | Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment. |
| Secondary | Change in HbA1c levels | throughout the study, about 1 year | Change in HbA1c levels from baseline after 12 weeks of treatment. |
| Secondary | Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function | throughout the study, about 1 year | Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment. |
| Secondary | proportion of subjects who withdrew | throughout the study, about 1 year | The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia. |
| Secondary | The safety profile | throughout the study, about 1 year | The safety profile of triple therapy with cofrogliptin. |
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.
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 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/NCT06863532
GET https://conductscience.org/api/trials/v1/NCT06863532/registered