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OPTI-2 (Diasome)
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A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults with Type 1 Diabetes Receiving Insulin Degludec
- Sex at Birth: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase II
- Conditions Being Studied: Diabetes Mellitus - Type 1
Study Purpose
The purpose of this study is to find out whether the addition of HDV to Humalog® will improve diabetes control by reducing high blood sugar after meals and/or reducing the risk of low blood sugar (hypoglycemia) during insulin treatment. The safety and tolerability of Humalog® with or without added HDV will also be evaluated
Who Can Participate
Age: 18-80
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: SITE00002228
- StudyID: 2024-01413
- ClinicalTrials.gov: NCT06238778
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