Completed PHASE2 INTERVENTIONAL 2-arm NCT02794155

Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1) (ISLE-1)

Phase 2b, Multicenter, Randomized, Double Blind, Titration Trial for Efficacy and Safety of HDV Insulin Lispro in Combination With a Basal Insulin Versus Insulin Lispro in Combination With a Basal Insulin in Patients With Type 1 Diabetes

Sponsor: Diasome Pharmaceuticals

Conditions Type 1 Diabetes Mellitus

Interventions HDV Insulin Lispro Insulin LISPRO

Updated 10 times since 2017 Last updated: Jul 29, 2018 Started: Jun 30, 2016 Primary completion: Apr 28, 2018 Completion: Jun 15, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Type 1 Diabetes Mellitus and is currently completed. Diasome Pharmaceuticals leads this study, which shows 10 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Aug 2018 — Jan 2021 [monthly]

Completed PHASE2

Status: Active Not Recruiting → Completed
Jun 2018 — Aug 2018 [monthly]

Active Not Recruiting PHASE2

▶ Show 5 earlier versions

Aug 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Apr 2017 — Aug 2017 [monthly]

Recruiting PHASE2
Mar 2017 — Apr 2017 [monthly]

Recruiting PHASE2
Feb 2017 — Mar 2017 [monthly]

Recruiting PHASE2
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE2

First recorded

Jun 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Diasome Pharmaceuticals
Integrium

Data source: Diasome Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Corona, United States , Denver, United States , Elgin, United States , Henderson, United States , Houston, United States , Idaho Falls, United States , Los Angeles, United States , Miami, United States , Norman, United States and 11 more locations