This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only
This phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study aims to assess the efficacy and safety of HDM1002 tablets in adult participants with T2DM inadequately controlled with diet and exercise only. A total of 360 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 2-week placebo run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1 ratio to receive different doses of HDM1002 or placebo 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
360
HDM1002 tablets, 200 mg once daily
HDM1002 tablets, 400 mg once daily
Placebo tablets, once daily
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange From Baseline in HbA1c at Week 40
Time frame: Week 40
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
Time frame: Week 40
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: Weeks 40
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Time frame: Weeks 40
Change From Baseline in Fasting plasma Glucose, fasting C-peptide and fasting insulin
The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL;C-Peptide and Fasting Insulin were measured at planned time points
Time frame: Weeks 40
Change from baseline in daily average levels of 7-point self-monitored blood glucose (SMBG) and mean postprandial glucose increment (all meals)
Time frame: Weeks 40
Change From Baseline in Postprandial 2-hour Glucose, C-Peptide, Insulin
These indicators were assessed using the mixed-meal tolerance test
Time frame: Weeks 40
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
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Time frame: Weeks 40
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)]
Time frame: Weeks 40
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Weeks 40
Change from baseline in Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) score
Time frame: Weeks 40
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.
Time frame: through study completion, an average of 1 year
Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination, Electrocardiogram and clinical laboratory evaluations
Time frame: through study completion, an average of 1 year