NCT06202079CompletedPhase 2
A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus
A Phase 2 Clinical Trial Comparing the Efficacy and Safety of Once-weekly GZR4 Injection Versus Once-daily Insulin Degludec in Subjects with Type 2 Diabetes Mellitus on OAD Therapy or OAD Therapy in Combination with Basal Insulin
Source: ClinicalTrials.gov · Last updated 23 Jan 2025
Brief summary (registry, in English)
This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with basal insulin.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 179 (actual)
- First submitted
- 2 Jan 2024
- Start date
- 11 Aug 2023
- Primary completion date
- 13 Jul 2024
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Diseases
- Type 2 diabetes
- NCT number
- NCT06202079
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 179
- From 11 Aug 2023 to the primary completion date, 13 Jul 2024
- 8 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.
Prior treatment
- Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
- Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
- History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
- Participation in a clinical study of another study drug within 3 month prior to randomization.
Other illness
- Presence or history of malignant neoplasm prior to screening.
- Known or suspected hypersensitivity to investigational medical product(s) or related products.
Other
- Female who is pregnant, breast-feeding.
Who the study is looking for
- Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
- Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
- Diagnosed with type 2 diabetes mellitus above or equal to 6 months
- 7.5% ≤ HbA1c ≤ 10.0% at screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Study Site 02 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Study Site 05 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Study Site 06 Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| Study Site 08 Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Study Site 01 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Study Site 07 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Study Site 03 Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Study Site 04 Coordinator of this site? Confirm its status | Zibo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.