BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarnot Laboratories
About this trial
The goal of this clinical trial is to evaluate the efficacy and safety of Bofanglutide (GZR18) compared with Semaglutide in Latin American adults with type 2 diabetes mellitus who have inadequate glycemic control while receiving stable metformin monotherapy. The main questions it aims to answer are:
Does Bofanglutide (GZR18) provide glycemic control comparable to Semaglutide based on changes in HbA1c? Is Bofanglutide (GZR18) safe and well tolerated in the study population? Can participants achieve glycemic targets and improve metabolic outcomes during treatment?
Researchers will compare participants receiving Bofanglutide (GZR18) with participants receiving Semaglutide to evaluate their effects on glycemic control, metabolic outcomes, safety, quality of life, and treatment satisfaction.
Participants will:
Be randomly assigned in a 1:1 ratio to receive Bofanglutide (GZR18) or Semaglutide.
Continue stable metformin monotherapy during the study. Receive subcutaneous study treatment with dose escalation according to the study protocol.
Participate in 30 weeks of active treatment. Attend scheduled study visits, laboratory assessments, and safety evaluations. Complete questionnaires related to quality of life and treatment satisfaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older who agree to participate in the study by voluntarily signing the Informed Consent Form.
Adult participants of either male or female sex.
Diagnosis of type 2 diabetes mellitus (T2DM) with a duration greater than 6 months, established according to the diagnostic and classification criteria for diabetes mellitus of the World Health Organization (WHO) in 1999, as well as the supplementary WHO diagnostic criteria of 2011, and in accordance with the widely accepted clinical criteria of the American Diabetes Association.
Background treatment with metformin monotherapy, at a stable dose for at least 90 days prior to screening, at a dose ≥1500 mg/day or at the maximum tolerated dose (MTD; ≥1000 mg/day), with no planned changes during the study.
Disqualifiers
Known or suspected hypersensitivity to GLP-1 type drugs or any of their excipients; or presence of contraindications for this type of medication.
Participation in clinical trials of other drugs or devices and having received treatment within the 3 months prior to the screening period.
Major surgery or surgical procedures with the potential to significantly alter body weight, intake, absorption, gastric emptying, mobility, or metabolic recovery.
Current use of non-antidiabetic medications that affect body weight.
Trial design
Design model
Parallel
Treatments tested in this trial
Bofanglutide
Biological/VaccineLong-acting GLP-1 receptor agonist administered as a subcutaneous injection every two weeks with dose escalation from 1.5 mg up to 18 mg according to the study protocol.
Semaglutide
Biological/VaccineGLP-1 receptor agonist administered as a weekly subcutaneous injection with dose escalation from 0.25 mg up to 1 mg according to the study protocol.
Treatment groups
374 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Bofanglutide (GZR18)Experimental treatment 1 intervention
Group B: Arm 2: SemaglutideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 30
Evaluation of the change in Hemoglobin A1c (HbA1c), expressed as percentage (%), from baseline to Week 30 during treatment
Time frame
Baseline to Week 30Secondary outcomes
1
Proportion of Participants Achieving Glycemic Targets (HbA1c <7.0% and ≤6.5%) at Week 30
To evaluate the proportion of participants achieving glycemic targets of HbA1c \<7.0% and ≤6.5% at Week 30 following treatment with Bofanglutide (GZR18) or Semaglutide.
Time frame
Baseline to Week 302
Change in Fasting Plasma Glucose From Baseline at Week 30
Evaluation of the change in fasting plasma glucose concentration from baseline to Week 30 during treatment
Time frame
Baseline to Week 303
Change in Hemoglobin A1c (HbA1c) From Baseline at Week 16
Evaluation of the change in Hemoglobin A1c (HbA1c) from baseline to Week 16 during treatment
Time frame
Baseline to Week 164
Change in Body Weight From Baseline at Week 30
Evaluation of the change in body weight, expressed in kilograms (kg), from baseline to Week 30 during treatment.
Time frame
Baseline to Week 30Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: