Trial | NCT02407899  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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) .
LADA is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet β 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 β 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 consent，the 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 β-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 β cell function than metformin (and insulin).
Study Started
Mar 31
2015
Primary Completion
Dec 30
2020
Study Completion
Dec 31
2020
Last Update
Apr 20
2021

Drug Saxagliptin

Take saxagliptin tablet 5mg p.o. qd. for 104 weeks after randomization.

  • Other names: Onglyza, Dipeptidyl peptidase 4 (DPP-4) inhibitor

Drug Vitamin D3

Take vitamin D drops 2000 IU p.o. qd. for 104 weeks after randomization.

  • Other names: Cholecalciferol

Drug Insulin

For optimal control of patients' glucose, researchers can initiate insulin therapy at any time in this trial, choose any brands of insulin after discussion with the patient.

  • Other names: Recombinant Human Insulin, Insulin analogue.

Drug Metformin

Take Metformin tablet 1.5g p.o. per day for 104 weeks (adjust the dose between 1-1.7g per day according to subject's specific situation) before or after randomization.

  • Other names: Metformin Hydrochloride tablet

Metformin (and insulin) + saxagliptin Experimental

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.

Metformin(insulin)+saxagliptin +vitamin D3 Experimental

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.

Metformin (and insulin) Active Comparator

Patients who have diagnosed LADA are assigned to receive Metformin 1.5g/d(and insulin at individual dose) for 104-week.

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.
No Results Posted