T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
The goal of this clinical study 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 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. 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 then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks. Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.
Interventions
DRUGHTD1801
HTD1801 1000 mg administered orally BID as four capsules
DRUGPlacebo
Matching placebo administered orally BID as 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 * Have followed dietary and exercise interventions for at least 8 weeks prior to screening * If used any glucose-lowering drugs within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 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 ≥19.0 kg/m\^2 to ≤35.0 kg/m\^2 Key
Exclusion criteria
* Have type 1 diabetes * Have had any acute diabetic complications within 12 months prior to screening * Have had any Grade 3 hypoglycemic event within 12 months prior to screening * Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot * 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 12 weeks prior to screening * Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * Have used any hypoglycemic drug during the 4-week run-in period prior to randomization * Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: Mean Change in HbA1c | 24 Weeks | Mean change in HbA1c from baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose | 24 Weeks | Mean change in fasting plasma glucose from baseline to Week 24 |
| DB Phase: Mean Change in 2-Hour Postprandial Glucose | 24 Weeks | Mean change in 2-hour postprandial glucose from baseline to Week 24 |
| DB Phase: Proportion of patients achieving HbA1c <7.0% | 24 Weeks | Proportion of patients achieving HbA1c target values of \<7.0% at Week 24 |
| DB Phase: Proportion of patients achieving HbA1c <6.5% | 24 Weeks | Proportion of patients achieving HbA1c target values of \<6.5% at Week 24 |
| DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR) | 24 Weeks | Mean change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from baseline to Week 24 |
| DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C) | 24 Weeks | Mean change in LDL-C from baseline to Week 24 |
Countries
China
Contacts
STUDY_DIRECTORKui Liu, MD
Shenzhen HighTide Biopharmaceutical Ltd.
Outcome results
None listed