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Clinical Trial Details

Trial ID: L2399
Source ID: NCT02059174
Associated Drug: Mk-1293
Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02059174/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: MK-1293|DRUG: EU-Lantus™|DRUG: Novolog™
Outcome Measures: Primary: Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study, Duration of Action (DOA) is defined as the length of time from dosing to End of Action. End of Action is defined as the time point at which plasma glucose has been above 150 mg/dL for 30 minutes and no glucose has been infused for 30 minutes. Median and max below are reported for the length of clamp duration (i.e. 30 hours)., Up to 30 hours postdose|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over 24 Hours After Dosing (GIR-AUC0-24hr), The area under the glucose infusion rate curve from hours 0 to 24 after injection (AUC\[GIR{0-24}\]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure., Up to 24 hours postdose|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the First 12 Hours After Dosing (GIR-AUC0-12hr), The area under the glucose infusion rate curve from hours 0 to 12 after injection (AUC\[GIR{0-12}\]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure., Up to 12 hours postdose|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the Second 12 Hours After Dosing (GIR-AUC12-24hr), The area under the glucose infusion rate curve from hours 12 to 24 after injection (AUC\[GIR{12-24}\]) for participants who received either MK-1293 or Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure., From 12 to 24 hours postdose|PD: Maximum Glucose Infusion Rate (GIRmax), Maximum glucose infusion rate (GIR\[max\]) based on smoothed data for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure., Up to 30 hours postdose|M1 Glargine Metabolite Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC0-24), M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Analysis was performed on log scale with results back transformed to the original scale, Up to 24 hours postdose|M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax), M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Analysis was performed on log scale with results back transformed to original scale., Up to 24 hours postdose | Secondary: M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the First 12 Hours After Dosing (AUC0-12), M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-12 is a measure of the total amount of drug in the plasma from the dose to Hour 12. Analysis was performed on log scale with results back transformed to original scale., Up to 12 hours postdose|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the Second 12 Hours After Dosing (AUC12-24), M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC12-24 is a measure of the total amount of drug in the plasma from Hour 12 to Hour 24. Analysis was performed on log scale with results back transformed to original scale., From 12 to 24 hours postdose
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 76
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-02-10
Completion Date: 2015-04-27
Results First Posted: 2017-03-08
Last Update Posted: 2018-09-05
Locations:
URL: https://clinicaltrials.gov/show/NCT02059174