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Recruiting NCT05307731

Fingolimod for Type 2 Diabetes Mellitus

Phase IV Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fingolimod, guideline-based treatment for DM.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study

Overview

The aim of this study is to explore the efficacy and safety of Fingoland in the treatment of type 2 diabetes. A total of 40 patients were randomly divided into two groups. One group was treated with fingolimod, another group was given guideline based treatment. The changes of islet function in patients with glycosylated hemoglobin, insulin and C-peptide were observed .

Interventions

  • Drug Fingolimod
    0.5mg daily for 90-180 days, in addition to guideline-based treatment for DM
  • Drug guideline-based treatment for DM
    guideline-based treatment for DM

Primary outcome measures

  • The changes of glycosylated hemoglobin, compared with baseline [Time frame: 180 days]
Secondary outcome measures (8)
  • The changes of glycosylated hemoglobin, compared with baseline [Time frame: 90 days, 120 days]
  • The changes of treatment drugs, compared with baseline [Time frame: 90 days, 120 days, 180 days]
  • The changes of 2-hour postprandial blood glucose, compared with baseline [Time frame: 30 days, 90 days, 120 days, 180 days]
  • The changes of fasting blood glucose, compared with baseline [Time frame: 30 days, 90 days, 120 days, 180 days]
  • Beta cell function, compared with baseline [Time frame: 30 days, 90 days, 120 days, 180 days]
  • The changes of insulin, compared with baseline [Time frame: 30 days, 90 days, 120 days, 180 days]
  • The changes of C-peptide, compared with baseline [Time frame: 30 days, 90 days, 120 days, 180 days]
  • any adverse events [Time frame: 180 days]

Eligibility criteria

Inclusion criteria

  • Age: 18-70 years old;
  • clinically diagnosed type 2 diabetes.
  • Glycosylated hemoglobin: 6.5% - 9.5%;
  • No drug treatment or only one oral hypoglycemic drug within 6 months;
  • Fasting blood glucose: < 13.9mmol/l for those without medication, or < 13.3mmol/l for those with medication;
  • if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months.
  • Body mass index (BMI) ≤ 45 kg / m2;
  • Sign informed consent

Exclusion criteria

  • patients with type 1 diabetes;
  • diabetic complications (ketoacidosis, hypertonic state, lactic acidosis).
  • Allergic to the study drug;
  • Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L);
  • Complicated with other serious organ diseases;
  • Recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure;
  • Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker;
  • Baseline QT interval extension (male > 450ms or female > 460ms);
  • Treatment with class IA or class III antiarrhythmic drugs;
  • Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.);
  • Participating in other clinical trials within 3 months;
  • Other circumstances that the investigator considers unsuitable for participating in this clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT05307731 · Y(2021)071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗