Type 2 diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: (Dulaglutide manufactured by Artiman Pharmed Alborz Company) for 18 weeks, as a subcutaneous injection first with a dose of 0.75 mg for 4 weeks and then a dose of 1
Sponsors
Artiman Pharmed Alborz Company
Eligibility
Sex/Gender
All
Age
25 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with type 2 diabetes for at least 3 months Age between 25 and 70 years when entering the study, applicable to both sexes. Consent to participate in the study and sign a written informed consent form 7.5 % = HbA1c = 10% BMI more than 25 and equal or less than 40
Exclusion criteria
Exclusion criteria: Patients who intend to participate in another clinical trial during the study. Patients with type 1 diabetes Patients who have used other GLP-1 or DPP4 receptor agonist drugs within 3 months before the study. Patients who are currently using bolus insulin for diabetes treatment (basal insulin use is allowed). Patients who have had a change in dose or type of diabetes medication in the 3 months prior to entering the study Patients who have had one or more hospitalizations in the past 6 months due to lack of diabetes control. Abnormalities in gastric emptying, such as severe diabetic gastroparesis or gastric outlet obstruction, and plans for bypass or obesity-related surgeries during the study. Have a history of a heart or brain problem such as heart attack, chest pain (except heartburn), angioplasty or stenting, or stroke within 6 months before screening. Patients with severe renal failure (GFR <30 mL/minute/1.73 m2) Patients with liver cirrhosis or alanine transaminase (ALT) levels greater than 3 times the upper limit of normal. Patients with active malignancy or patients who are recovering from cancer in less than 5 years. Patients with a history of organ transplantation. Patients with a blood disorder that affects blood sugar measurements or laboratory samples Pregnant or lactating women or women who intend to become pregnant during the study period History of chronic or acute pancreatitis. Personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 Diagnosis of proliferative retinopathy or maculopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin (HbA1C) change at week 18 compared to baseline. Timepoint: At the beginning and week 18. Method of measurement: Measuring by the central laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemic control (change in fasting blood sugar) at week 18 compared to the baseline. Timepoint: At the baseline and week 18. Method of measurement: Measuring of fasting blood sugar by the central laboratory.;Weight changes in the 18th week compared to the baseline state. Timepoint: At the baseline and week 18. Method of measurement: Using digital weight scale.;The proportion of patients who achieve an HbA1c of less than 7. Timepoint: Week 18. Method of measurement: Dichotomized HbA1c level at the cut-off of 7.;Frequency of side effects or serious side effects during 18 weeks. Timepoint: 7 days after the screening visit, 1+7 days after the 1st visit, 3+28 days after the 1st visit, 3+42 days after the 1st visit, 3+56 days after the 1st visit, 3+70 days after the visit 1, 84+3 days after visit 1, 98+3 days after visit 1, 112+3 days after visit 1, 126+3 days after visit 1. Method of measurement: Self-reporting by the individual during in-person and phone visits.;Frequency of patients with anti-drug antibodies. Timepoint: Week 18. Method of measurement: Elisa test on patients' sera. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRamin Heshmat
Tehran University of Medical Sciences
Outcome results
None listed