NCT07198932Not yet recruiting
Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes
Effectiveness and Safety of Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Chinese Adults With Type 2 Diabetes Mellitus: a Multicenter, Prospective Real-world Study (COLOR-REAL)
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 594 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Yanbing Li
- Diseases
- Type 2 diabetes
- NCT number
- NCT07198932
What you commit to
- Study type: Observational
- Planned participants: 594
- From 1 Oct 2025 to the primary completion date, 31 Jul 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic to the study drug.
- Diagnosed with type 1 diabetes.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| The First Medical Center of Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Luhe Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Xi'an International Medical Center Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.