Investigating the effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on controlling blood sugar, weight, vitamin D and lipid profile of patients

Effect of standard treatment of three drugs empagliflozin + linagliptin + metformin (trijardi xr) on BMI, lipid profile, vitamin D in type 2 diabetic patients resistant to two drugs metformin + sitagliptin, referring to the endocrinology clinic

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240215061021N1

Enrollment

Registered

2024-03-10

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 Diabetes. Type 2 diabetes mellitus

Interventions

At the beginning of the study, patients' FBS, HBA1C, BMI, lipid profile and vitamin D are evaluated. After the patients entered the present study, they were treated with the combined drug of empaglifl

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: bmi range between 25 and 45 Patients with diabetes resistant to treatment with gliclazide or metformin Age more than 18 years Hba1c should be between 7 and 10.5 Fbs less than 250 Gfr more than 30 No change in treatment =12 weeks before the study be treated with metformin + sitagliptin combination drug

Exclusion criteria

Exclusion criteria: GFR<30 History of recurrent urinary tract infections History of frequent urination Bmi less than 25 ACS, STROKe or TIA in the last three months Bariatric surgery at least two years ago Be susceptible to lactic acidosis or pancreatitis Dm1 Pregnancy

Design outcomes

Primary

Measure	Time frame
Fasting blood sugar. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.;HbA1c. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.	—

Secondary

Measure	Time frame
Lipid profile. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.;Vitamin D. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.;BMI. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: How to calculate BMI: Weight (kg) / height squared (m2) BMI.	—

Measure

Time frame

Lipid profile. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.;Vitamin D. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: Measurement through variable measurement by laboratory diagnostic kit.;BMI. Timepoint: before the start of the study and three months after the start of treatment. Method of measurement: How to calculate BMI: Weight (kg) / height squared (m2) BMI.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasim Shirinsahrae

Dezfoul University of Medical Sciences

drn.shirin1398@gmail.com+98 61 4242 2040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026