Type 2 diabetes
Conditions
Interventions
Experimental group:Dose Escalation Phase: ABP2111Na tablets were administered for 28 consecutive days, with dose-escalation studies proposed to begin at 25 mg and 50 mg, with the 3rd dose group determ
Placebo group:ABP2111Na placebo tablets were administered for 28 consecutive days in a proposed dose-escalation study starting at 25 mg, 50 mg, with the 3rd dose group determined based on safety, PK/P
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Enrollment is only possible if all of the following conditions are met: 1. Between 18 and 65 years of age (including borderline values), with an appropriate male to female ratio; 2. Body mass index (BMI = weight (kg)/height^2 (m^2)) between 18.0 and 32 kg/m^2 (including borderline values) and weighing >=45 kg; 3. Diagnosed with type 2 diabetes mellitus according to the 1999 WHO criteria; 4. 7.0% = 1500 mg/day or the maximum tolerated dose of the subject) (the confirmation of the entry row of HbA1c was based on the local hospital test results); 5. Priority enrollment in each dose group of this study will be given to subjects with type 2 diabetes mellitus combined with non-alcoholic fatty liver disease (NAFLD) with >=8% hepatic fat content as shown by MRI-PDFF (results of MRI-PDFF performed at the trial center within 28 days prior to randomization will be accepted); 6. Agree not to use any glucose-lowering medication other than the study drug during this study; 7. Voluntarily participate and sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: Persons who meet one of the following conditions are not eligible for enrollment: 1. Persons with a history of allergy or known hypersensitivity to any component of the product; 2. Persons with type 1 diabetes mellitus, diabetes mellitus with a single gene mutation, or diabetes mellitus secondary to a disease such as Cushing's syndrome or acromegaly, or diabetes mellitus due to pancreatic injury; and persons with other endocrine system disorders that are not well-controlled (e.g., hyperthyroidism, hypothyroidism, and hypercortisolism); provided, however, that patients who have a chronic disease other than type 2 diabetes mellitus (e.g., hypercholesterolemia) but are treated with a diet or a stabilized dose of medication may be enrolled controlled (e.g., may enroll patients with hypercholesterolemia who are receiving appropriate treatment); 3. Those who are on glucose-lowering therapy with insulinotropic agents (sulfonylureas and glinides) and/or insulin and/or GLP-1 agonists within 1 month prior to screening; 4. Acute metabolic complications (ketoacidosis, clinically significant ketosis, lactic acidosis, or hyperosmolar comatose state) within 6 months prior to screening; 5. Presence or history of hematological disorders, neoplasms, renal disorders, endocrine disorders, pulmonary disorders, gastrointestinal disorders, cardiovascular disorders, hepatic disorders, psychiatric disorders, and neurological disorders that may affect subject safety or determination of study results; 6. Prior history of proliferative retinopathy and macular disease; 7. Prior history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or calcitonin >= 50 pg/ml; 8. Presence of current infection requiring systemic administration of medication for infection control; 9. Dysphagia, or a condition that interferes with gastrointestinal absorption (e.g., inflammatory bowel disease, active ulcers), or a gastrointestinal condition that is assessed by the investigator as an increased risk for post-dose administration (e.g., gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.), or who have undergone gastrointestinal surgery that can lead to malabsorption or who have received long-term medications/treatments that have an effect on gastrointestinal motility [ such as those who have undergone bariatric surgery or operations (e.g. gastric banding)]; 10. Persons who are on weight loss medication at screening or plan to take weight loss medication during the study, or who have taken weight loss medication within 3 months prior to screening, or who have had a change in weight of more than 10% in the 3 months prior to screening; 11. Prior history of symptomatic gallbladder disease, pancreatic cancer, acute or chronic pancreatitis, or acute or chronic pancreatitis at screening; 12. Two or more episodes of severe hypoglycemia within 3 months prior to screening; 13. A history of decompensated heart failure (NYHA classification III and IV); a history of unstable angina pectoris, stroke or transient ischemic attack, or persistent and clinically significant cardiac arrhythmia (e.g., frequent preterm systole) within 6 months; a history of hypertension with a systolic blood pressure (SBP) >=150 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg after application of a stable dose (at least 4 weeks) of antihypertensive medi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile;Pharmacodynamic (PD) profile;Changes in BMI, weight, waist circumference, waist-to-hip ratio and fasting lipid levels;Cardiac safety (concentration-QTc intervals);Hepatic fat fraction measured by MRI-PDFF;Changes in HbA1c;Blood glucose, insulin, C-peptide, glucagon, and glucagon like peptide-1 (including total GLP-1 and active GLP-1), etc.;Changes in insulin cell function;Changes in insulin production indices;Change in insulin resistance index (HOMA-IR); | — |
Countries
China
Contacts
Public ContactXiaoli Li / Huan Zhou
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed