Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Xiangya Hospital of Central South University
• Collaborators: Beijing Hospital; First Affiliated Hospital of Chongqing Medical University; National Clinical Research Center for Metabolic Diseases, China; The First Affiliated Hospital of Henan University of Science and Technology; The First Affiliated Hospital with Nanjing Medical University
• Treatments: Cholecalciferol; Dipeptidyl-Peptidase IV Inhibitors; Ergocalciferols; Insulin; Insulin, Globin Zinc; Metformin; Saxagliptin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;

2. 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:

1. Pregnancy, breastfeeding or planned pregnancy within two years;

2. Gestational diabetes mellitus or other specific types of diabetes;

3. Allergic to saxagliptin, vitamin D3 and their excipient;

4. Treatment with any anti-diabetic medication other than insulin in the last 8 weeks prior to randomization;

5. Use of systemic corticosteroids therapy (oral, intravenous) continuously for more than 7 days over the past 6 months;

6. Treatment with cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitor;

7. 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;

8. 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;

9. History of malignant tumors;

10. History of mental disorders;

11. History of alcohol abuse or illegal drug abuse;

12. Serious systemic disease which the investigators think would not be suitable for the study.