type2 diabetes
Conditions
Interventions
administrate tirzepatide starting at a dose of 2.5 mg once weekly, the dose being increased to 5 mg after four weeks and maintained until the study endpoint at 12 weeks.
Sponsors
Kansai Electric Power Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) type2 diabetes 2) baseline HbA1c level < 12.0% 3) BMI >=25 kg/m2 4) with or without metformin monotherapy at a stable dose
Exclusion criteria
Exclusion criteria: (i) diagnosis of type 1 diabetes or other type of diabetes, (ii) hypoglycemic agent other than metformin, (iii) medication or disease affecting glycemic management or body composition (corticosteroids, thyroid disease, malignancy, etc.), (iv) hospitalization within the observation period, (v) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase level >=2 times the normal upper limit), (vi) renal dysfunction (estimated glomerular filtration rate of <45 mL/min/1.73 m2), (vii) severe cardiac dysfunction (New York Heart Association class>II), (viii) judgment by the researchers for any other reason of ineligibility to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glucose infusion required rate in the hyperinsulinemic-euglycemic clamp analysis from baseline to 12 weeks after the start of tirzepatide | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in HbA1c, fasting plasma glucose, body weight, body composition (muscle mass, fat mass, fat percentage), fasting lipid profile (triglycerides, HDL cholesterol, LDL cholesterol), fasting glucagon levels, HOMA2-IR, HOMA2-%be-ta, and the correlations between the changes of these measurements and glucose infusion required rate. | — |
Countries
Japan
Contacts
Public ContactHitoshi Kuwata
Kansai Electric Power Hospital Center for Diabetes, Endocrinology and Metabolis
Outcome results
None listed