Last updated on August 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Insulin dependent diabetes mellitus
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

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(132mol/L) for males and 1.4 mg/dL (123mol/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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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