type 2 diabetes mellitus
Conditions
Interventions
weekly subcutaneously injection of 2 mg exenatide extended-release for 24 weeks
oral administration of 50 mg of sitagliptin once daily for 24 weeks
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients with type 2 diabetes mellitus - normotensive patients or well-controlled hypertensive patients
Exclusion criteria
Exclusion criteria: - patients contraindicated to the study drugs - patients treated with insulin - patients with uncontrollable hypertension - pregnant women or women who are possibly pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcomes are estimated 24 weeks after start of treatment: - Changes in blood pressure by ambulatory blood pressure monitoring - Changes in office blood pressure - Ratios of patients requiring changes in doses or contents of medications | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following factors are estimated 24 weeks after start of treatment: - fasting blood sugar and HbA1c - inflammation: hsCRP - renal function: urinary protein/creatinine ratio, urinary albumin/creatinine ratio, and eGFR - renin-angiotensin system Blood: plasma renin activity, aldosterone, prorenin, and soluble (pro)renin receptor. Urine: prorenin, soluble (pro)renin receptor, and angiotensinogen - body weight, waist circumference, visceral fat area, and hANP - endothelial function: flow-mediated dilation - arterial stiffness: baPWV | — |
Countries
Japan
Contacts
Public ContactSatoshi Morimoto
Tokyo Women's Medical University Department of Medicine II
Outcome results
None listed