Type 2 Diabetes
Conditions
Interventions
Experimental group and placebo group:In the 24 weeks treatment phase, take test product or placebo three times a day
In the 24 weeks extended treatment phase, both groups take same test medicine
Sponsors
Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The main inclusion criteria are as follows: 1. Patients who can fully understand and voluntarily sign informed consent, and can comply with all trial requirements; 2. Patients with type 2 diabetes who met the WHO diagnostic criteria (1999); 3. Life style intervention and 1 ~ 2 oral hypoglycemic drugs stable treatment for more than 2 months of patients with poor efficacy. Oral hypoglycemic agents include metformin monotherapy, metformin combined with dipeptidyl peptidase IV (DPP-4) inhibitors, metformin combined with alpha-glucosidase inhibitors or metformin combined with sulfonylureas. The dosage of metformin should be >=1500mg / D and <=2000mg/d. Metformin combined with oral hypoglycemic drugs: the dosage of metformin is the same as that of single drug treatment, and other oral hypoglycemic drugs use conventional clinical treatment dose; (1) 0 mmol/L and <=13. 0 mmol/L; (2) When screening, HbA1c 7.0% to 10.5% (central laboratory); 4. Male or female aged 18 to 70 years; 5. Patients with BMI between 18.5 and 30 kg / m2 (including the critical value).
Exclusion criteria
Exclusion criteria: The main exclusion criteria are as follows: 1. Patients with non-type 2 diabetes, such as type 1 diabetes mellitus, diabetes mellitus with definite single gene mutation, diabetes caused by pancreatic injury or other secondary diabetes mellitus; 2. For patients with any of the following medical history or clinical conditions, the researchers believe that the risk of participating in the study is greater than the benefit, or the treatment of combined diseases may affect the compliance of the subjects or the objectivity of the study endpoint: (1) There are serious chronic complications of diabetes; (2) There was a history of acute diabetic complications in 3 months before screening; (3) There are serious respiratory, circulatory, digestive, neuropsychiatric, blood, endocrine system, immune system diseases; (4) novel coronavirus pneumonia is present in acute and chronic infectious diseases; (5) He has a history of malignant tumor in recent 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ), or has potential malignant tumor at present; (6) There are gastrointestinal diseases that may affect drug absorption; 3. Patients who have received any of the following medication or treatment: (1) Systemic glucocorticoid therapy (except inhaled or topical glucocorticoid therapy) was used within 1 month before screening or planned during the study period; (2) Glucagon like peptide-1 (GLP-1) analogues or receptor agonists, sodium glucose cotransporter 2 (sglt-2) inhibitors, and thiazolidinedione (TZD) were used within 3 months before screening or during the study; (3) Continuous use of insulin for more than 7 days within 3 months before screening, or planned to use insulin during the study period (except for drugs allowed in the protocol during the study period); (4) Weight control drugs (including weight loss drugs) were used within 3 months before screening or planned to be used during the study period, or undergoing weight loss surgery, or weight change > 5 kg in the 3 months before screening period; (5) Participated in other hypoglycemic drug related clinical studies within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in HbA1c after 24 weeks of treatment with ORMD-0801 in type 2 diabetes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in HbA1c after 12, 36, and 48 weeks of treatment;The proportion of subjects with HbA1c=6.5% and HbA1c<7.0% after 12 weeks, 24 weeks, 36 weeks, and 48 weeks treatment.;Changes from baseline in fasting intravenous blood glucose and 2 hours postprandial intravenous blood glucose after 12, 24, 36 and 48 weeks treatment;Changes in body weight and body mass index (BMI) from baseline after 24 and 48 weeks treatment.;The proportion of subjects who were rescued during the core treatment period and the duration of the rescue treatment.;Safety indicators including post-treatment adverse event (TEAE) rate, vital signs, physical examination, laboratory examination, 12-lead electrocardiogram examination, and hypoglycemia events will be used to assess the safety of treatment with combined ORMD-0801 versus combined placebo;Positive conversion rate of anti-insulin antibody after 12, 24, and 48 weeks treatment;Serum Insulin concentration test at fasting and 2 hours postprandial after 12, 24, 36, 48 weeks treatment;Serum C-peptide concentration test at fasting and 2 hours postprandial after 12, 24, 36, 48 weeks treatment;After 12, 24, 36, 48 weeks treatment, for subjects in selected study centers, blood samples will be collected 1h and 3h after meal, in addition to collecting at fasting and 2h after meal, to detect serum insulin concentration;After 12, 24, 36, 48 weeks treatment, for subjects in selected study centers, blood samples will be collected 1h and 3h after meal, in addition to collecting at fasting and 2h after meal, to detect serum C-peptide concentration;After 12, 24, 36, 48 weeks treatment, for subjects in selected study centers, blood samples will be collected 1h and 3h after meal, in addition to collecting at fasting and 2h after meal, to detect blood glucose; | — |
Countries
China
Contacts
Public ContactGuang Ning
Ruijin Hospital
Outcome results
None listed