A Cohort Study of Incretin-based Therapy Combined With Insulin in Type 2 Diabetic Patients for 5 Years

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The use of dipeptidyl-peptidase 4 (DPP-4) inhibitors and glucagon like peptide 1 (GLP1) analogues for the treatment of diabetic mellitus (DM) type 2 is growing (1,2). Currently, some of these agents have been approved in combination with insulin. The potential for combined use with insulin has garnered increasing attention due to reduce side effects associated with insulin therapy and improve glycemic control. Some investigators reported that GLP-1 analogue combined with insulin reduces HbA1c and weight with low risk of hypoglycemia and high treatment satisfaction (3). However, their duration of treatment was short time with less than a mean of 3.0 years and the alterations of chronic diabetic complications by combination with incretin-based and insulin therapies are not known.

We evaluated the long effects of adding incretin-based therapy (DPP-4 inhibitors or GLP-1 analogues) to insulin therapy on glycated hemoglobin (HbA1c) as glycemic control, body mass index (BMI), blood pressure (BP), insulin dosage, frequency of hypoglycemia, and chronic diabetic complications for 5 years-treatments.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nagaoka Red Cross Hospital
• Treatments: Incretins; Insulin

Criteria

Inclusion Criteria:

After a detailed baseline examination, 500 Japanese subjects with type 2 diabetes were followed up for all-cause mortality and morbidity. All participants visited our clinic regularly. All patients were fully informed about the purposes and procedures for the study and provided oral consent at enrolment.

Exclusion Criteria:

Patients participating in other clinical study. Other than the above, patients judged inappropriate as the subjects of this study by the investigator.