CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01468519
NCT01468519Phase 4Completed

Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial

Jothydev's Diabetes and Research Centre·interventional·Posted Nov 9, 2011·Updated Dec 11, 2014

In Brief

A Phase 4 clinical trial evaluating Insulin for Diabetes Mellitus, Type 2 and Erectile Dysfunction. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 9, 2011
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.6 years ago

Interventions

Insulindrug

Insulin via continuous subcutaneous insulin infusion

Insulindrug

insulin via multiple daily injections