Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-29 @ 12:31 AM
Study NCT ID:
NCT06863532
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate 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 therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.
Detailed Description:
The primary objective of this study is to evaluate 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 therapy with SGLT2i and metformin.
The secondary objectives of this study are to evaluate the changes in the following parameters (for indicators requiring pre-post comparison, the baseline level during the baseline treatment period is used for comparison):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 therapy with SGLT2i and metformin:
1. The proportion of subjects with HbA1c \< 7.0% and \< 6.5% after 24 weeks of treatment.
2. Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment.
3. Change in HbA1c levels from baseline after 12 weeks of treatment.
4. Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
5. The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
6. The safety profile of triple therapy with cofrogliptin.
The secondary objectives of this study are to evaluate the changes in the following parameters (for indicators requiring pre-post comparison, the baseline level during the baseline treatment period is used for comparison):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 therapy with SGLT2i and metformin:
1. The proportion of subjects with HbA1c \< 7.0% and \< 6.5% after 24 weeks of treatment.
2. Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment.
3. Change in HbA1c levels from baseline after 12 weeks of treatment.
4. Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
5. The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
6. The safety profile of triple therapy with cofrogliptin.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: