| Trial ID: | L4104 |
| Source ID: | NCT00883558
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| Associated Drug: |
Insulin Lispro
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| Title: |
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00883558/results
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| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Insulin Lispro|DRUG: regular human insulin|DRUG: recombinant human hyaluronidase PH20|DRUG: Insulin glargine
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| Outcome Measures: |
Primary: Postprandial Glucose Excursion, A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented., Week 14 and Week 26 | Secondary: Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring, Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented., Week 14 and Week 26|Number of Participants With Hypoglycemic Events, The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module., Baseline through Week 29
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| Sponsor/Collaborators: |
Sponsor: Halozyme Therapeutics
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
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| Start Date: |
2009-05
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| Completion Date: |
2010-04
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| Results First Posted: |
2014-09-08
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| Last Update Posted: |
2014-09-08
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| Locations: |
Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Diabetes Research Institute, Miami, Florida, 33136, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Mercury Street Medical, Butte, Montana, 59701, United States|UNC Diabetes Care Center/Highgate Specialty Center, Durham, North Carolina, 27713, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States|West Olympia Internal Medicine, Olympia, Washington, 98502, United States
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| URL: |
https://clinicaltrials.gov/show/NCT00883558
|
