Type 2 Diabetes Mellitus
Conditions
Brief summary
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
Detailed description
This Phase 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will be randomized 1:1:1 to receive HTD1801 500 mg twice daily (BID), HTD1801 1000 mg BID, or placebo BID.
Interventions
DRUGHTD1801
HTD1801 administered orally BID as two capsules
DRUGPlacebo
Matching placebo administered orally BID as two to four capsules
Sponsors
Shenzhen HighTide Biopharmaceutical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria * Have followed dietary and exercise interventions for at least 8 weeks prior to screening * Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization) * Have fasting plasma glucose \<13.9 mmol/L (screening and pre-randomization) * Have a body mass index ≥18 kg/m\^2 to ≤40 kg/m\^2 Key
Exclusion criteria
* Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.) * Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening * Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening * Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening * Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening * Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening * Have used any glucose-modifying medications within 8 weeks prior to screening * Have had weight gain or loss ≥5% from screening to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in HbA1c | 12 Weeks | Mean change in HbA1c from baseline to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in fasting plasma glucose | 12 Weeks | Mean change in fasting plasma glucose from baseline to Week 12 |
| Proportion of patients achieving HbA1c <7.0% | 12 Weeks | Proportion of patients achieving HbA1c \<7.0% after 12 weeks of treatment |
| Proportion of patients achieving HbA1c <6.5% | 12 Weeks | Proportion of patients achieving HbA1c \<6.5% after 12 weeks of treatment |
| Mean change in postprandial glucose | 12 Weeks | Mean change in postprandial glucose from baseline to Week 12 |
| Mean change in low-density lipoprotein cholesterol (LDL-C) | 12 Weeks | Mean change in LDL-C from baseline to Week 12 |
Countries
China
Contacts
STUDY_DIRECTORKui Liu
Shenzhen HighTide Biopharmaceutical Ltd.
Outcome results
None listed