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Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients

NCT01468519 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-12-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Insulin

Insulin via continuous subcutaneous insulin infusion

DRUG

Insulin

insulin via multiple daily injections

Sponsors & Collaborators

  • Jothydev's Diabetes and Research Centre

    lead OTHER

Principal Investigators

  • Jothydev Kesavadev, MD · Jothydev's Diabetes & Research Center

  • Gopika Krishnan, BPHARM · Jothydev's Diabetes & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-09-30
Completion
2014-11-30

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468519 on ClinicalTrials.gov