To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT Number: NCT06481085
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Type 2 Diabetes
Interventions: DRUG: HDM1002 50 mg|DRUG: HDM1002 100 mg|DRUG: HDM1002 200 mg|DRUG: HDM1002 400 mg|DRUG: HDM1002 200 mg BID|DRUG: Placebo
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 318
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2025-04-30
Locations: The Chinese People's Liberation Army General Hospital, Beijing, Beijing, 100039, China|Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, China|Peking University Shougang Hospital, Beijing, China|Cangzhou Central Hospital, Cangzhou, China|The Second Hospital of Jilin University, Changchun, China|The Fourth Hospital of Changsha City, Changsha, China|The Third Hospital of Changsha City, Changsha, China|Chengdu Second People's Hospital, Chengdu, China|The Affiliated Hospital of Chengdu University, Chengdu, China|Three Gorges Hospital Affiliated to Chongqing University, Chongqing, China|The First Hospital of Handan City, Handan, China|Zhejiang Provincial People's Hospital, Hangzhou, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China|The Second Affiliated Hospital of Anhui Medical University, Hefei, China|Huizhou Central People's Hospital, Huizhou, China|Huzhou Central Hospital, Huzhou, China|Jinan Central Hospital, Jinan, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China|The Third People's Hospital of Luoyang City, Luoyang, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China|The First Affiliated Hospital of Nanyang Medical College, Nanyang, China|The First People's Hospital of Nanyang City, Nanyang, China|Panjin Liaohe Oilfield General Hospital, Panjin, China|The First Hospital of Qinhuangdao City, Qinhuangdao, China|Suzhou Municipal Hospital, Suzhou, China|The First Hospital of Shanxi Medical University, Taiyuan, China|Tonghua Central Hospital, Tonghua, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China|Xuzhou Cancer Hospital, Xuzhou, China|Yueyang People's Hospital, Yueyang, China|The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, China

Summary:
This is a randomized, double-blind, placebo controlled, parallel group study, which aims to provide data on efficacy, safety and pharmacokinetics (PK) of multiple dose levels of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise.

Primary Outcome Measures: Change From Baseline in HbA1c at Week 12, HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control, Baseline, Week 12
Secondary Outcome Measures: Change From Baseline in HbA1c at Week 4, Week 8, HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control, Baseline, Week 4, Week 8|Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5%, The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 12|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., Baseline, Week 12|Change From Baseline in Postprandial 2-hour Glucose (PPG2h), Area Under the Curve of Plasma Glucose (AUC0-4h, Glucose), C-Peptide (AUC0-4h, C-peptide), Insulin (AUC0-4h, Insulin), and Glucagon (AUC0-4h, Glucagon), These indicators were assessed using the mixed-meal tolerance test, Baseline, Week 12|Change From Baseline in Fasting C-Peptide, Fasting Insulin, and Fasting Glucagon, C-Peptide, Fasting Insulin, and Fasting Glucagon were measured at planned time points, Baseline, Week 12|Change From Baseline in Homeostasis Model Assessment of β-Cell Function (HOMA-β) and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), HOMA-IR and HOMA-β are commonly used to estimate insulin resistance and beta cell function., Baseline, Week 12|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., Baseline, Week 12|Change From Baseline in Systolic and Diastolic Blood Pressure, Blood Pressure was measured using an automated device, Baseline, Week 12|Change From Baseline in Body Weight, Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 12|Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%, Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 12|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., Baseline Through Week 16|Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram, Vital signs (blood pressure, pulse rate, body temperature, respiratory rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase), Baseline Through Week 16
Other Outcome Measures: Change From Baseline in Glycaemic Indicators According to Treatment Background ( Metformin or Diet and Exercise Alone), Glycaemic Indicators include HbA1c (%), fasting plasma glucose (mmol/L) and 2-hour postprandial blood glucose (mmol/L), Baseline, Week 12|Change From Baseline in Body Weight According to Treatment Background ( Metformin or Diet and Exercise Alone), Weight in kilograms, Baseline, Week 12|Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible), PK parameters including: Maximum plasma concentration (Cmax), Minumum plasma concentration (Cmin), Time to maximum plasma concentration (Tmax), AUCtau, Area under the curve from time 0 to 24 h(AUC0-24h), Baseline, Day 71