drugset / Trial / NCT01468519

Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients

NCT01468519

Phase 4 Completed 20 enrolled Jothydev's Diabetes and Research Centre
RandomizedParallel-groupSingle-blindTreatment

Summary

Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic control increases the risk ED. Although comparatively costly, advantages of CSII over other modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and improved quality of life. In a previously published study, on CSII in T2DM, in our center, 83% of men reported an improvement in sexual function as a secondary endpoint. The current study is planned to further explore this finding.

Timeline

Start
2012-01
Primary completion
2014-09
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic Subcutaneous