Clinical trial NCT06202079: A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
2. Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
3. Diagnosed with type 2 diabetes mellitus above or equal to 6 months
4. 7.5% ≤ HbA1c ≤ 10.0% at screening.

Exclusion Criteria:

1. Female who is pregnant, breast-feeding.
2. Presence or history of malignant neoplasm prior to screening.
3. Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
4. Known or suspected hypersensitivity to investigational medical product(s) or related products.
5. Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
6. 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.
7. Participation in a clinical study of another study drug within 3 month prior to randomization.

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (week 0) to week 16
Secondary outcomes:
measure: Change in fasting plasma glucose(FPG)
timeFrame: From baseline (week 0) to week 16
measure: Weekly doses of GZR4 Injection/Insulin Degludec
timeFrame: Week 15-16
measure: Incidence and Rate of Treatment-emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to week 20
measure: Incidence and Rate of hypoglycemia episodes
timeFrame: From baseline (week 0) to week 20
measure: Change in ADA of GZR4
timeFrame: From baseline (week 0) to week 16
measure: Change in Nab of GZR4
timeFrame: From baseline (week 0) to week 16
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Study Site 07
state: Hubei
city: Changzhou
country: China
facility: Study Site 06
state: Jiangsu
city: Jinan
country: China
facility: Study Site 08
state: Shandong
city: Zibo
country: China
facility: Study Site 04
state: Shandong
city: Xi'an
country: China
facility: Study Site 03
state: Shanxi
city: Beijing
country: China
facility: Study Site 02
city: Beijing
country: China
facility: Study Site 05
city: Tianjin
country: China
facility: Study Site 01
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Chunyue Hao
role: STUDY_DIRECTOR
References: