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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT02407899
• Date of registration: 31/03/2015
• Prospective Registration: No
• Primary sponsor: Second Xiangya Hospital of Central South University
• Public title: Protective Effects of Saxagliptin (And Vitamin D3) on ß Cell Function in Adult-onset Latent Autoimmune Diabetes
• Scientific title: A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin)
• Date of first enrolment: March 2015
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02407899
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Zhiguang Zhou, MD/PhD
• Affiliation: Second Xiangya Hospital of Central South University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: Insulin

Drug: Metformin

Drug: Saxagliptin

Drug: Vitamin D3

Primary Outcome(s)

Absolute changes from baseline in Fasting C-peptide levels at week 104. [Time Frame: From baseline to 104 week]

Secondary Outcome(s)

The increased percentage of C peptide pre-and post mixed-meal tolerance test (Delta C peptide) after 104 weeks of treatment. [Time Frame: From baseline to 104 week]

Changes of average daily insulin dose (U/kg/d) from baseline and at week 26, 52, 78 and 104 [Time Frame: From baseline to 26, 52, 78, 104 week]

Changes of GADA titers from baseline and at week 52 and 104. [Time Frame: From baseline to 52, 104 week]

Changes of HbA1c levels from baseline and at week 26, 52, 78 and 104. [Time Frame: 26, 52, 78, 104 week]

The proportion of subjects responding to glucose therapy (i.e. HbA1c<7%) after 104 weeks of treatment. [Time Frame: 104 week]

Absolute changes of body weight and BMI level from baseline and at week 26, 52, 78 and 104. [Time Frame: From baseline to 26, 52, 78, 104 week]

The proportion of subjects with increased (decreased, unchanged) fasting or post-stimulus C peptide level compared with baseline after 104 weeks of treatment. [Time Frame: From baseline to 104 week]

Absolute changes from baseline in C peptide at 60-min and 120-min (AUC) during a mixed-meal tolerance test and at week 26, 52, 78 and 104. [Time Frame: From baseline to 26, 52, 78, 104 week]

Absolute changes from baseline in fasting C-peptide levels and at week 26, 52 and 78. [Time Frame: From baseline to 26, 52, 78 week]

Secondary ID(s)

NCRCMD LADA SAX 2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

First Affiliated Hospital of Chongqing Medical University

Beijing Hospital

The First Affiliated Hospital with Nanjing Medical University

The First Affiliated Hospital of Henan University of Science and Technology