Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)
Public ClinicalTrials.gov record NCT02794155. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).
Study identification
- NCT ID
- NCT02794155
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 157 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2016 (Type not available)
- Primary completion
- Apr 28, 2018 (Actual)
- Completion
- Jun 15, 2018 (Actual)
- Last update posted
- Jul 31, 2018
2016 – 2018
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hope & Wellness Clinical Trials, Inc. | Corona | California | 92882 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| California Medical Research Associates Inc. | Northridge | California | 91324 | — |
| Bay Area Clinical Research | San Carlos | California | 94070 | — |
| Mills-Peninsula Health Services | San Mateo | California | 94401 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80209 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | — |
| Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach | Florida | 32174 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | — |
| Rocky Mountain Diabetes & Osteoporosis Center, PA | Idaho Falls | Idaho | 83404 | — |
| Associates in Endocrinology | Elgin | Illinois | 60124 | — |
| University of Massachusetts Memorial Hospital | Worcester | Massachusetts | 01655 | — |
| Desert Endocrinology Clinical Research Center | Henderson | Nevada | 89052 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| LION Research | Norman | Oklahoma | 73072 | — |
| Endocrine and Psychiatry Center | Houston | Texas | 77095 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02794155, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2018 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02794155 live on ClinicalTrials.gov.