POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorServier Russia

About this trial

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women aged 18 years and older.

Patients with type 2 diabetes.

Written informed consent of the patient to participate in the study.

No conditions that require emergency medical aid.

Disqualifiers

Known hypersensitivity to luseogliflozin or other components of Lusefi®.

Type 1 diabetes.

Decompensated type 2 diabetes.

Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study.

Trial population

patients with type 2 diabetes in real-world clinical practice Every investigator is expected to include about 4 patients that meet the inclusion/exclusion criteria. Inclusion period will last up to 6 months.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)

Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline

Time frame
6 months

Secondary outcomes

1

Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)

Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline.

Time frame
6 months
2

Effectiveness of luseogliflozin on Body weight

Change in Body weight (BW) at Visit 3 compared to baseline.

Time frame
6 months
3

Effectiveness of luseogliflozin on systolic blood pressure (SBP)

Change in systolic blood pressure (SBP) at Visit 3 compared to baseline

Time frame
6 months
4

Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)

Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.

Time frame
6 months

Other outcomes

Sponsors and contacts

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