Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring LADA, saxagliptin, vitamin D3, C-Peptide
Eligibility Criteria
Inclusion Criteria:
- Volunteer to participate in the study with informed consent;
- The LADA patients to be included in this study are defined as:
(1) Meet the 1999 WHO Diagnostic Criteria for Diabetes Mellitus; (2) Age at diagnosis of DM ≧ 18 years old; (3) Glutamic acid decarboxylase antibody (GADA) positive; (4) Serum fasting C-peptide ≥ 100 pmol/L or 2-hour postprandial C-peptide≥ 200 pmol/L; 3. Age between 18-70 years old; 4. Diabetes duration <4 year; 5. Outpatient or inpatient.
Exclusion Criteria:
- Pregnancy, breastfeeding or planned pregnancy within two years;
- Gestational diabetes mellitus or other specific types of diabetes;
- Allergic to saxagliptin, vitamin D3 and their excipient;
- Treatment with any anti-diabetic medication other than insulin in the last 8 weeks prior to randomization;
- Use of systemic corticosteroids therapy (oral, intravenous) continuously for more than 7 days over the past 6 months;
- Treatment with cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitor;
- Alanine aminotransferase (ALT) or aspartate transaminase(AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
- Creatinine levels ≧ 1.5 mg/dL(132μmol/L) for males and ≧ 1.4 mg/dL (123μmol/L) for females or creatinine clearance ≦ 50 mL/min;
- History of malignant tumors;
- History of mental disorders;
- History of alcohol abuse or illegal drug abuse;
- Serious systemic disease which the investigators think would not be suitable for the study.
Sites / Locations
- Peking University People's Hospital
- Beijing Hospital of the Ministry of Health
- The First Affiliated Hospital of Chongqing Medical University
- Quanzhou First Hospital, Fujian
- The First Affiliated Hospital of Fujian Medical University
- Gansu Provincial Hospital
- Dongguan People's Hospital
- Guangdong General Hospital
- Guangzhou First People's Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- The First Affiliated Hospital of Guangxi Medical University
- Hainan General Hospital
- Tangshan Gongren Hospital063000
- Tangshan Gongren Hospital
- Harbin Medical University
- The First Affiliated Hospital of Henan University of Science and Technology
- Henan Provincial People's Hospital
- The First People's Hospital of Changde
- Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
- The First Affiliated Hospital of South China University
- The Second Hospital University of South China
- The First People's Hospital of Huaihua
- The First People's Hospital of Yueyang
- The Affiliated Hospital of Inner Mongolia Medical University
- Jiangsu Province Hospital
- The Northern Jiangsu People's Hospital
- The First Affiliated Hospital of Nanchang University
- The Third Affiliated Hospital of Nanchang University
- The Second Hospital of Jilin University
- Jilin Province People's Hospital
- The First Hospital of China Medical University
- The Affiliated Hospital of Qingdao University
- Shanghai Xuhui District Central Hospital
- Heping Hospital of Changzhi Medical College
- Affiliated Heji Hospital of Changzhi Medical College
- The First Affiliated Hospital of The Fourth Military Medical University
- First People's Hospital of Yunnan Province
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- The Second Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Metformin (and insulin) + saxagliptin
Metformin(insulin)+saxagliptin +vitamin D3
Metformin (and insulin)
Patients who have diagnosed LADA are assigned to receive Saxagliptin tablets 5mg/d and Metformin 1.5g/d (and insulin at individual dose) for 104-week.
Patients who have diagnosed LADA are assigned to receive Saxagliptin tablets 5 mg/d, vitamin D drop 2000IU/d, Metformin 1.5g/d (and insulin at individual dose) for 104-week.
Patients who have diagnosed LADA are assigned to receive Metformin 1.5g/d(and insulin at individual dose) for 104-week.