Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes

NCT07198932 | Not Yet Recruiting

• 1 other identifier: IIT-2025-340
• Study Type: observational
• Target: 594
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a multicenter, prospective, non-interventional real-world study to evaluate the clinical outcomes of biweekly cofrogliptin versus daily linagliptin as an add-on therapy in Chinese adult T2D patients.

Conditions

Type 2 Diabetes

Keywords

real-world study; cofrogliptin; DPP-4i; insulin

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  from baseline to 24 weeks

Secondary Outcomes (8)

• Change in HbA1c

  from baseline to 12 weeks

• Reaching of HbA1c target (defined as HbA1c less than 7%)

  at 24 weeks

• Change in FPG

  from baseline to 24 weeks

• Change in PPG

  from baseline to 24 weeks

• Change in fasting C peptide

  from baseline to 24 weeks

Other Outcomes (4)

• Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

  at baseline, 12 weeks and 24 weeks

• Short-Form 36 Health Survey (SF-36)

  at baseline, 12 weeks and 24 weeks

• Drug adherence

  at 24 weeks

Study Arms (2)

Cofrogliptin cohort

Drug: Cofrogliptin add to insulin

Linagliptin cohort

Drug: Linagliptin add to insulin

Interventions

Cofrogliptin add to insulin DRUG

Patients will be treated with commercially available cofrogliptin according to routine clinical practice at the discretion of the treating physician.

Cofrogliptin cohort

Linagliptin add to insulin DRUG

Patients will be treated with commercially available linagliptin according to routine clinical practice at the discretion of the treating physician.

Linagliptin cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Real-world adult population with type 2 diabetes in China.

You may qualify if:

• Sign the informed consent form.
• Aged ≥18 years.
• Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria).
• Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total.
• Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent.

You may not qualify if:

• Allergic to the study drug.
• Diagnosed with type 1 diabetes.
• Unable to comply with study-specific procedures.
• Current or planned pregnant, or currently breastfeeding.
• With any other situation judged by the investigator, that is unsuitable for participation in this trial.

Sponsors & Collaborators

• Yanbing Li: lead

Study Sites (7)

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Affiliated Hospital of Hebei University

Baoding, China

Location

Beijing Luhe Hospital Affiliated to Capital Medical University

Beijing, China

Location

the First Medical Center of Chinese PLA General Hospital

Beijing, China

Location

Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Location

Shanghai Changzheng Hospital

Shanghai, China

Location

Xi'an International Medical Center Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (7)