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Clinical Trial Details

Trial ID: L5991
Source ID: NCT00774800
Associated Drug: Humalog
Title: Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00774800/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Humalog|DRUG: Humulin-R|DRUG: Recombinant human hyaluronidase PH20 (rHuPH20)|OTHER: Liquid meal
Outcome Measures: Primary: Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60), AUC was derived as the area under the serum insulin concentration profile from 0 to time "t." Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose., Predose up to 60 minutes postdose | Secondary: Maximum Serum Insulin Concentration (Cmax), Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose., Predose up to 480 minutes postdose|Time to Maximum Serum Insulin Concentration (Tmax), Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose., Predose up to 480 minutes postdose|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG]), AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose., Predose up to 4 hours after injection of study drug
Sponsor/Collaborators: Sponsor: Halozyme Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: |Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2008-10
Completion Date: 2009-03
Results First Posted: 2014-09-05
Last Update Posted: 2019-02-26
Locations: Profil Institute for Clinical Research, Inc., Chula Vista, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT00774800