End-stage renal disease caused by type 2 diabetes
Conditions
Interventions
Once-weekly oral administration of omarigliptin (12.5mg) for 6 months.
Once-daily oral administration of linagliptin (5mg) for 6 months.
Sponsors
Niigata University Graduate School of Medical and Dental Sciences Department of Applied Molecular Medicine
Shinrakuen Hospital Nagaoka Red Cross Hospital Nagaoka Chuo General Hospital Sado General Hospital Kido Hospital Niigata Saiseikai Sanjo Hospital Koyo Medical Clinic Maihira Clinic University of Niigata Prefecture Gunma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those undergoing maintenance hemodialysis for more than 6 months. 2. Those aged 20 or over, with type 2 diabetes treated with DPP-4 inhibitors for more than 3 months. 3. Those who have given written informed consent on the use of their clinical data for this trial.
Exclusion criteria
Exclusion criteria: 1. Those undergoing maintenance hemodialysis for more than 6 months. 2. Those aged 20 or over, with type 2 diabetes treated with DPP-4 inhibitors for more than 3 months. 3. Those who have given written informed consent on the use of their clinical data for this trial. 1. Those who have been treated with GLP-1 receptor agonists. 2. Those with hypersensitivity to DPP-4 inhibitors or GLP-1 receptor agonists. 3. Those with serious diabetic ketosis, coma, or pre-coma. 4. Those with severe active infection, serious trauma, or in the perioperative period. 5. Those with severe heart or liver dysfunction 6. Those with problems shown as below: 1) Pituitary gland or adrenal gland dysfunction 2) In the status of impaired nutrition, starvation, irregular or insufficient dietary intake, or hyposthenia. 3) Excessive muscular exercise 4) Heavy alcohol drinkers. 7. Those who are pregnant or beast-feeding, or those who might be pregnant 8. Those with uncontrolled hyper glycaemia (GA >=27% or HbA1c >=9%), on their current treatment with the oral medicine. 9. Those who are considered not eligible for this trial by attending doctors due to any medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in glycoalbumin (GA) and HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. The change in the scores of Development and Psychometric Validation of the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire. 2. The change in body composition evaluated by using InBody. 3. The change of blood glucose, GLP-1, GIP, and glucagon during hemodialysis treatment. 4. The change in the interdialytic weight gain rate. Safety outcomes 1. Frequency of serious adverse events associated with the use of omarigliptin. 2. Frequency of hypoglycemia events associated with the use of omarigliptin. | — |
Countries
Japan
Contacts
Public ContactMichihiro Hosojima
Niigata University Graduate School of Medical and Dental Sciences Department of Clinical Nutrition Science
Outcome results
None listed