Diabetes, Type 2 Diabetes
Conditions
Brief summary
This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes.
Detailed description
This trial is conducted in China. The aim of the trial is to investigate the efficacy and safety of an Bamboo cane polysaccharide (oral LC-Z300-01) in subjects with type 2 diabetes. Considering the rights and interests, the trial is divided into two phases. The first phase is a double-blind group, in which subjects are randomly assigned to the blank control group, the low-dose experimental group, and the high-dose experimental group to observe the changes in glycosylated hemoglobin and CGMS compared with the baseline, as well as safety events. The second phase is an open-label group, in which the three groups are willing to freely enter the high-dose experimental group and further observe recovery and safety.
Interventions
DIETARY_SUPPLEMENTPlacebo twice daily in blinding
Administered placebo twice-daily for 12 weeks in blinding
DRUGLow-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
DRUGHigh-dose LC-Z300-01 twice daily in blinding
Administered twice-daily for 12 weeks in blinding
DRUGHigh-dose LCZ300-1 twice daily in open-label
Administered high-dose LCZ300-1 twice-daily for 12 weeks in open-label
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The total duration of the trial for individuals participating in this clinical trial is up to 30 weeks, including: 1. 3-week screening period, 2. 1-week run-in period (may be extended to a maximum of 8 weeks), 3. 12-week double-blind randomized, controlled intervention period, 4. 12-week switching to high-dose conversion, open-label intervention period, 5. 2-week follow-up period. For subjects with an extended run-in period, the trial duration can be up to 37 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age reach and over 18 years at the time of signing informed consent, * Body mass index (BMI) between 18.0 and 35.0 kg/m\^2 (both inclusive), * Type 2 diabetes mellitus (as diagnosed clinically) before screening. * hemoglobin A1c of 7.5 - 9.0% (both inclusive) as assessed by central laboratory on the day of screening, * Treated with stable doses of oral antidiabetic drugs (OADs) , insulin or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide, etc.) within 3 months prior to screening;
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method, * Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids), * Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening, * Presence or history of pancreatitis (acute or chronic) within 180 days before screening, * Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. Chronic heart failure classified as being in New York Heart Association Class IV at screening, * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events | From baseline week 0 to week 26 | The differences in adverse events between the patients taking the drug and the placebo group were observed during the double-blind and open-label phases. |
| Change in glycated haemoglobin (HbA1c) | From baseline week 0 to week 12 and to week 24 | During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Range (TIR) | From baseline week 0 to week 12 and to week 24 | During the double-blind and open-label phases, the changes in dynamic blood glucose and CGMS values of patients taking the medication compared with the baseline were observed and compared with those in the placebo group. |
Countries
China
Contacts
Primary ContactWei-fen Xie, Prof.
Backup ContactTuo Li, Prof.
Outcome results
None listed