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

NCT02407899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-04-20

No results posted yet for this study

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) .

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Saxagliptin

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

DRUG

Vitamin D3

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

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.

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.

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Henan University of Science and Technology

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Zhiguang Zhou, MD/PhD · Second Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-12-30
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02407899 on ClinicalTrials.gov