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Clinical Trial Details

Trial ID: L6456
Source ID: NCT02059161
Associated Drug: Mk-1293
Title: A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02059161/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: MK-1293|DRUG: Lantus™|DRUG: Prandial Insulin
Outcome Measures: Primary: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C., Baseline and Week 24|Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24, Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline., Up to Week 24|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24, Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline., Up to Week 24|Change From Baseline in AIA Titer After 24 Weeks of Treatment, This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer., Baseline and Week 24|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24, Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment., Up to Week 24 | Secondary: Change From Baseline in A1C at Week 52, A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C., Baseline and Week 52|Total Insulin Dose at Week 24, Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication)., Week 24|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24, Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication)., Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0., Baseline and Week 24|Percentage of Participants With Confirmed Positive AIA Up Through Week 52, Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline., Up to Week 52 including baseline|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52, Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline., Up to Week 52|Change From Baseline in AIA Titer After 52 Weeks of Treatment, This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0., Baseline and Week 52|Total Insulin Dose at Week 52, Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication)., Week 52|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52, Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication)., Week 52|Change From Baseline in FPG at Week 52, Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0., Baseline and Week 52|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52, Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment., Up to Week 52|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24, The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning., Baseline and Week 24|Change From Baseline in 7-point SMBG at Week 52, The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning., Baseline and Week 52|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment., Percentage of participants attaining A1C glycemic goals of \<7.0% and \<6.5% after 24 weeks of treatment., 24 weeks|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment., Percentage of participants attaining A1C glycemic goals of \<7.0% and \<6.5% after 52 weeks of treatment., 52 weeks|Basal Insulin Dose at Week 52, Basal Insulin Dose at Week 52., Week 52|Basal Insulin Dose Per kg of Body Weight at Week 52, Basal Insulin Dose per kg of Body Weight at Week 52., Week 52|Bolus Insulin Dose at Week 52, Bolus Insulin Dose at Week 52., Week 52|Bolus Insulin Dose Per kg of Body Weight at Week 52, Bolus Insulin Dose per kg of Body Weight at Week 52., Week 52|Basal Insulin Dose at Week 24, Basal Insulin Dose at Week 24., Week 24|Basal Insulin Dose Per kg of Body Weight at Week 24, Basal Insulin Dose per kg of Body Weight at Week 24., Week 24|Bolus Insulin Dose at Week 24, Bolus Insulin Dose at Week 24., Week 24|Bolus Insulin Dose Per kg of Body Weight at Week 24, Bolus Insulin Dose per kg of Body Weight at Week 24., Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 508
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-10-17
Completion Date: 2015-11-12
Results First Posted: 2017-03-08
Last Update Posted: 2018-09-05
Locations:
URL: https://clinicaltrials.gov/show/NCT02059161