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Clinical Trial Details

Trial ID: L2077
Source ID: NCT01275131
Associated Drug: Insulin Aspart
Title: Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01275131/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Insulin aspart|DRUG: Recombinant human hyaluronidase PH20 (rHuPH20)
Outcome Measures: Primary: Early Insulin Exposure (%AUC[0-60]), Stage 1, Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve \[AUC{0-360}\]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp., 10 minutes predose up to 60 minutes postdose|Early Exposure to Insulin (%AUC[0-60]), Stage 3, Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve \[AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp., 10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10 | Secondary: Maximum Glucose Infusion Rate (GIRmax), Stage 1, Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Maximum Glucose Infusion Rate (GIRmax), Stage 3, Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1, Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3, Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1, Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on day 2/6 and Day 4/8|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3, Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Time to 50% Total Glucose Infused (50%Gtot), Stage 1, Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Time to 50% Total Glucose Infused (50%Gtot), Stage 3, Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1, Area under the glucose concentration curve for 0 to 360 minutes (AUC\[0-360\]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3, Area under the glucose concentration curve from 0 to 360 minutes (AUC\[0-360\]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1, Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC\[0-360\]) by the area under the concentration versus time curve (AUC\[0-360\]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3, Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC\[0-360\]) by the area under the concentration versus time curve (AUC\[0-360\]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp., 10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
Sponsor/Collaborators: Sponsor: Halozyme Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 45
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2011-01
Completion Date: 2011-12
Results First Posted: 2014-07-25
Last Update Posted: 2014-07-25
Locations: Profil Institute for Clinical Research, Chula Vista, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT01275131