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Fingolimod for Type 2 Diabetes Mellitus

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fingolimod

    Drug

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

  • guideline-based treatment for DM

    Drug

    guideline-based treatment for DM

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fingoland groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The changes of glycosylated hemoglobin, compared with baseline

Time frame
180 days

Secondary outcomes

1

The changes of glycosylated hemoglobin, compared with baseline

Time frame
90 days, 120 days
2

The changes of treatment drugs, compared with baseline

including drug numbers and doses

Time frame
90 days, 120 days, 180 days
3

The changes of 2-hour postprandial blood glucose, compared with baseline

Time frame
30 days, 90 days, 120 days, 180 days
4

The changes of fasting blood glucose, compared with baseline

Time frame
30 days, 90 days, 120 days, 180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Shenyang Military Region

Lead sponsor

Source ClinicalTrials.gov
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