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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2021
  • participants needed
    300
  • sponsor
    Second Xiangya Hospital of Central South University
Updated on 18 August 2019
Investigator
Zhiguang Zhou, Professor
Primary Contact
The Northern Jiangsu People's Hospital (2.0 mi away) Contact
+38 other location
diabetes
insulin
metformin
c-peptide
autoimmune diabetes
glutamic acid

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 cell function than metformin(and insulin) .

Description

LADA is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet cells and triggered by environmental factors based on genetic susceptibility. LADA shows some characteristics of type 2 diabetes at its onset, which develops slowly and latent, and easily be misdiagnosed as type 2 diabetes due to slowly cell function deterioration. This is a multi-center, open- label, 1:1:1 randomized controlled trial to investigate the protective effects of saxagliptin and vitamin D3 in LADA patients. The study comprises the 0-6weeks of screening period and the 104-week intervention period. After obtaining the informed consentthe screening will find out the eligible patients according to the inclusion/exclusion criteria, then the patients will be randomized to the 104-week intervention period. Subjects will be randomized into one of the three groups(arms) through central dynamic randomization: metformin (and insulin), metformin(and insulin) +saxagliptin, metformin(and insulin) +saxagliptin+vitamin D3. Our previous randomized- controlled pilot study showed that dipeptidyl peptidase 4 (DPP-4) inhibitors could significantly improve islet -cell function in patients with LADA. The main purpose of this study: To evaluate whether saxagliptin (and vitamin D3) with metformin (and insulin) therapy can better protect islet cell function than metformin (and insulin).

Details
Treatment insulin, Metformin, Saxagliptin, Vitamin D3
Clinical Study IdentifierNCT02407899
SponsorSecond Xiangya Hospital of Central South University
Last Modified on18 August 2019

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Insulin dependent diabetes mellitus?
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(132mol/L) for males and 1.4 mg/dL (123mol/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
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