This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.
This phase 3, multi-center, randomized, double-blind, active-controlled, parallel group study aims to assess the efficacy and safety of HDM1002 tablets in adult participants with T2DM inadequately controlled on metformin monotherapy. A total of 800 participants will be randomized in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or \> 8.5%). Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a 4-week metformin run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or dapagliflozin once daily for 52 weeks, followed by an approximate 4-week follow-up. During the treatment period, dose escalation will occur every 4 weeks until the target dose is reached. The evaluation of the primary endpoint will be conducted at Week 40.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
800
HDM1002 tablets, 100 mg once daily, 52 weeks
HDM1002 tablets, 200 mg once daily, 52 weeks
HDM1002 tablets, 400 mg once daily, 52 weeks
Yueyang People's Hospital
Yueyang, Hunan, China
RECRUITINGChange From Baseline in HbA1c at Week 40
HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control
Time frame: Baseline, Week 40
Change From Baseline in HbA1c at Week 52
HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control
Time frame: Baseline, Week 52
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% with or without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
The target HbA1c level for people with diabetes is usually less than 7%.
Time frame: Baseline, Week 40, Week 52
Change From Baseline in Fasting plasma Glucose
The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL
Time frame: Baseline, Weeks 40, Week 52
Change from baseline in fasting C-peptide and fasting insulin
C-Peptide and Fasting Insulin were measured at planned time points
Time frame: Baseline, Weeks 40, Week 52
Change from baseline in homeostasis model assessment of β-cell function (HOMA-β) and insulin resistance (HOMA-IR)
HOMA-IR and HOMA-β are commonly used to estimate insulin resistance and beta cell function
Time frame: Baseline, Weeks 40, Week 52
Change From Baseline in Postprandial 2-hour Glucose (PPG2h), Area Under the Curve of Plasma Glucose (AUC0-2h, Glucose), C-Peptide (AUC0-2h, C-peptide), Insulin (AUC0-2h, Insulin)
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dapagliflozin 10mg will be provided
These indicators were assessed using the mixed-meal tolerance test
Time frame: Baseline, Weeks 40, Week 52
Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)
7-point SMBG was used to assess glycemic variability and the efficacy of treatment
Time frame: Baseline, Weeks 40, Week 52
Change from baseline in body weight, body mass index (BMI), and waist circumference
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time frame: Baseline, Weeks 40, Week 52
Percentage change from baseline in body weight
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Time frame: Baseline, Weeks 40, Week 52
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Time frame: Baseline, Weeks 40, Week 52
Change From Baseline in Fasting Lipid Profiles, including: Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Total Cholesterol (TC), Non-HDL-C and Lipoprotein (a) [Lp(a)]
Fasting Lipid Profiles were measured at planned time points
Time frame: Baseline, Weeks 40, Week 52
Change From Baseline in Systolic and Diastolic Blood Pressure
Blood Pressure was measured using an automated device
Time frame: Baseline, Weeks 40, Week 52
Change from baseline in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) score
DTSQs is a validated, patient-reported outcome measure designed to assess current treatment satisfaction in people with diabetes
Time frame: Baseline, Weeks 40, Week 52
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]), Adverse Events of Special Interest (AESI), Incidence and Severity of Hypoglycaemic Events, etc.
A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect
Time frame: Baseline through Week 56
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination, Electrocardiogram and clinical laboratory evaluations
Vital signs (blood pressure, pulse rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase) and diabetic retinopathy assessments
Time frame: Baseline through Week 56