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Clinical Trial Details

Trial ID: L5853
Source ID: NCT01311076
Associated Drug: Tak-329
Title: TAK-329 Glucose Clamp Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: TAK-329|DRUG: TAK-329|DRUG: Insulin|DRUG: Placebo
Outcome Measures: Primary: (AUCGIR 0-360): Area Under the Curve of the Glucose Infusion Rate From Time 0 to 360 minutes post dose Pharmacodynamic Parameter., (AUCGIR 0-360) is measure of area under the curve of the glucose infusion rate from time 0 to 360 minutes (6 hours) post dose, measured in minutes during the glucose clamp procedure., On Day 1 in Four Treatment Periods.|GIRmax: Maximum Observed Glucose Infusion Rate Pharmacodynamic Parameter., Maximum observed glucose infusion rate (GIRmax) is the peak glucose infusion rate of a drug after administration, obtained directly from the glucose infusion-time curve, measured in minutes during the glucose clamp procedure., On Day 1 in Four Treatment Periods.|TGIRmax: Time to Reach the Maximum Glucose Infusion Rate (GIRmax) Pharmacodynamic Parameter., TGIRmax: Time to reach the maximum Glucose Infusion Rate (GIRmax), equal to time (hours) to GIRmax, measured in minutes during the glucose clamp procedure., On Day 1 in Four Treatment Periods. | Secondary: Maximum Observed Pharmacodynamic Response (Emax) of Cortisol During Hypoglycemic Clamp., The maximum observed increase or decrease (peak) effect for cortisol, based off sample collected at the start of the clamp procedure, 0 hours predose, and 0. 5, 1.0, 2, 3, 4 and 6 hours postdose. Hypoglycemic clamp procedure is a method for quantifying insulin secretion and resistance, used to measure glucose metabolism and insulin sensitivity., On Day 1 in Four Treatment Periods.|Area under the effect versus time curves (AUEC) of Cortisol During Hypoglycemic Clamp., Area under the effect-time curve calculated using the linear trapezoidal rule for cortisol, based off sample collected at the start of the clamp procedure, 0 hours predose, and 0. 5, 1.0, 2, 3, 4 and 6 hours postdose. Hypoglycemic clamp procedure is a method for quantifying insulin secretion and resistance, used to measure glucose metabolism and insulin sensitivity., On Day 1 in Four Treatment Periods.|Incidence of Treatment-Emergent Adverse Events., Incidence of treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing., After receiving first dose of study drug and within 30 days after receiving the last dose of study drug.|Incidence of Hypoglycemia., Incidence of hypoglycemia (abnormal low blood sugar) classified into 4 categories: Severe Hypoglycemia (participant experiences confusion or disorientation requiring resuscitative action); Symptomatic Hypoglycemia (blood glucose of \<55 mg/dL accompanied by clinically significant signs and symptoms of hypoglycemia); Biochemical Hypoglycemia (blood glucose \<50 mg/dL preferably confirmed by second reading, regardless of accompanying symptoms or signs of hypoglycemia); and Other Hypoglycemia (any signs or symptoms considered by investigator indicative of hypoglycemia, regardless of glucose value)., After receiving first dose of study drug and Day 7 +/-2 after receiving the last dose of study drug.
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose:
Start Date: 2011-03
Completion Date: 2012-01
Results First Posted:
Last Update Posted: 2012-02-13
Locations: Chula Vista, California, United States
URL: https://clinicaltrials.gov/show/NCT01311076