NCT06199505CompletedPhase 2
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 28 Dec 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 28 Jun 2024
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Diseases
- Type 2 diabetes
- NCT number
- NCT06199505
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 153
- From 21 Nov 2023 to the primary completion date, 28 Jun 2024
- 1 site 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
- Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
- Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
- Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
- Participation in a clinical study of another study drug within 1 month prior to randomization.
Other illness
- Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
- Known or suspected hypersensitivity to trial product(s).
Other
- Women in pregnancy or lactation.
Who the study is looking for
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- BMI = 18.5-35 kg/m2 (inclusive) at screening.
- Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
- 7.0% ≤ HbA1c ≤ 11.0% at screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gan & Lee Pharmaceuticals Co., Ltd Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.