7 completed. 6 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 6 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec HDV-Lispro, Lispro - Diabetes Mellitus, Type 1 | Phase 2 | Completed | Diasome Pharmaceuticals | 227 | 2023-12-28 | 2026-07-31 |
| Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec HDV-Insulin Lispro and Insulin Degludec (-40%), HDV-Insulin Lispro and Insulin Degludec (-10%) - Diabetes Mellitus, Type 1 | Phase 2 | Completed | Diasome Pharmaceuticals | 61 | 2019-03-18 | 2020-04-02 |
| 21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus HDV insulin lispro 100 UNIT/mL, Insulin Lispro 100 Units/mL - Type1 Diabetes Mellitus | Phase 2 | Completed | Diasome Pharmaceuticals | 24 | 2017-05-18 | 2018-07-31 |
| Comparison of Hepatic Directed Vesicle (HDV)-Insulin Lispro Versus Insulin Lispro to Further Improve Glycemic Control HDV insulin lispro 100 UNT/ML, Insulin Lispro 100 UNT/ML - Diabetes Mellitus, Type 1 | Phase 2 | Completed | Diasome Pharmaceuticals | 46 | 2017-04-18 | 2018-07-31 |
| Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1) HDV Insulin Lispro, Insulin LISPRO - Type 1 Diabetes Mellitus | Phase 2 | Completed | Diasome Pharmaceuticals | 157 | 2016-06-01 | 2018-07-31 |
| Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus placebo, Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15), Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) - Diabetes | Phase 2 / Phase 3 | Completed | Diasome Pharmaceuticals | 239 | 2008-12-01 | 2021-05-26 |
| A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | Completed | Diasome Pharmaceuticals | 6 | 2007-09-17 | 2021-05-14 |
Diabetes Mellitus, Type 1 (5) · Diabetes Mellitus (2) · Diabetes Mellitus, Type 2 (1)
Insulin Lispro (4) · insulin degludec (1)
United States (7)
David Klonoff, MD (1) · David Orloff, MD (1) · Douglas B Muchmore, MD (1) · Douglas Muchmore, MD (1) · Len Rosenberg, PhD, RPh (1) · Marc Penn, MD, PhD (1) · Ruth Weinstock, MD (1)