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A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-1293
Lantus™
Prandial Insulin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T1DM For at least 1 year
  • is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day.
  • is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication

Exclusion Criteria:

  • has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months
  • history of ketoacidosis in the last 6 months
  • participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L].
  • history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients
  • used a formulation of insulin glargine other than Lantus™
  • has received injectable incretin-based therapy within the past 8 weeks
  • on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks
  • has undergone bariatric surgery within the past 12 months
  • is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted)
  • has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study
  • has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder
  • has severe peripheral vascular disease
  • has high blood pressure
  • has chronic myopathy, or a progressive neurological or neuromuscular disorder
  • has active nephropathy
  • history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • has human immunodeficiency virus (HIV)
  • has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • history of malignancy in the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • history of melanoma, leukemia, lymphoma, or renal cell carcinoma
  • is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks
  • is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
  • is pregnant or breast-feeding, or is expecting to conceive or donate eggs
  • has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study
  • has poor mental function or works the night shift

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MK-1293

    Lantus

    Arm Description

    MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    Total Insulin Dose at Week 24
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    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).
    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.
    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.
    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.
    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.
    Total Insulin Dose at Week 52
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    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).
    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.
    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.
    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.
    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.
    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.
    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.
    Basal Insulin Dose at Week 52
    Basal Insulin Dose at Week 52.
    Basal Insulin Dose Per kg of Body Weight at Week 52
    Basal Insulin Dose per kg of Body Weight at Week 52.
    Bolus Insulin Dose at Week 52
    Bolus Insulin Dose at Week 52.
    Bolus Insulin Dose Per kg of Body Weight at Week 52
    Bolus Insulin Dose per kg of Body Weight at Week 52.
    Basal Insulin Dose at Week 24
    Basal Insulin Dose at Week 24.
    Basal Insulin Dose Per kg of Body Weight at Week 24
    Basal Insulin Dose per kg of Body Weight at Week 24.
    Bolus Insulin Dose at Week 24
    Bolus Insulin Dose at Week 24.
    Bolus Insulin Dose Per kg of Body Weight at Week 24
    Bolus Insulin Dose per kg of Body Weight at Week 24.

    Full Information

    First Posted
    February 7, 2014
    Last Updated
    August 7, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02059161
    Brief 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)
    Official Title
    A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 17, 2013 (Actual)
    Primary Completion Date
    May 4, 2015 (Actual)
    Study Completion Date
    November 12, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    508 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-1293
    Arm Type
    Experimental
    Arm Description
    MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
    Arm Title
    Lantus
    Arm Type
    Active Comparator
    Arm Description
    Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
    Intervention Type
    Drug
    Intervention Name(s)
    MK-1293
    Intervention Description
    MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
    Intervention Type
    Drug
    Intervention Name(s)
    Lantus™
    Other Intervention Name(s)
    Insulin glargine
    Intervention Description
    Lantus™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
    Intervention Type
    Drug
    Intervention Name(s)
    Prandial Insulin
    Intervention Description
    Participants will continue their prandial insulin during the study.
    Primary Outcome Measure Information:
    Title
    Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
    Description
    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.
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24
    Description
    Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.
    Time Frame
    Up to Week 24
    Title
    Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24
    Description
    Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.
    Time Frame
    Up to Week 24
    Title
    Change From Baseline in AIA Titer After 24 Weeks of Treatment
    Description
    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.
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24
    Description
    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.
    Time Frame
    Up to Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in A1C at Week 52
    Description
    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.
    Time Frame
    Baseline and Week 52
    Title
    Total Insulin Dose at Week 24
    Description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    Time Frame
    Week 24
    Title
    Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24
    Description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    Time Frame
    Week 24
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
    Description
    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.
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants With Confirmed Positive AIA Up Through Week 52
    Description
    Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline.
    Time Frame
    Up to Week 52 including baseline
    Title
    Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52
    Description
    Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline.
    Time Frame
    Up to Week 52
    Title
    Change From Baseline in AIA Titer After 52 Weeks of Treatment
    Description
    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.
    Time Frame
    Baseline and Week 52
    Title
    Total Insulin Dose at Week 52
    Description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    Time Frame
    Week 52
    Title
    Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52
    Description
    Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
    Time Frame
    Week 52
    Title
    Change From Baseline in FPG at Week 52
    Description
    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.
    Time Frame
    Baseline and Week 52
    Title
    Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52
    Description
    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.
    Time Frame
    Up to Week 52
    Title
    Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24
    Description
    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.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in 7-point SMBG at Week 52
    Description
    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.
    Time Frame
    Baseline and Week 52
    Title
    Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.
    Description
    Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment.
    Time Frame
    24 weeks
    Title
    Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.
    Description
    Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.
    Time Frame
    52 weeks
    Title
    Basal Insulin Dose at Week 52
    Description
    Basal Insulin Dose at Week 52.
    Time Frame
    Week 52
    Title
    Basal Insulin Dose Per kg of Body Weight at Week 52
    Description
    Basal Insulin Dose per kg of Body Weight at Week 52.
    Time Frame
    Week 52
    Title
    Bolus Insulin Dose at Week 52
    Description
    Bolus Insulin Dose at Week 52.
    Time Frame
    Week 52
    Title
    Bolus Insulin Dose Per kg of Body Weight at Week 52
    Description
    Bolus Insulin Dose per kg of Body Weight at Week 52.
    Time Frame
    Week 52
    Title
    Basal Insulin Dose at Week 24
    Description
    Basal Insulin Dose at Week 24.
    Time Frame
    Week 24
    Title
    Basal Insulin Dose Per kg of Body Weight at Week 24
    Description
    Basal Insulin Dose per kg of Body Weight at Week 24.
    Time Frame
    Week 24
    Title
    Bolus Insulin Dose at Week 24
    Description
    Bolus Insulin Dose at Week 24.
    Time Frame
    Week 24
    Title
    Bolus Insulin Dose Per kg of Body Weight at Week 24
    Description
    Bolus Insulin Dose per kg of Body Weight at Week 24.
    Time Frame
    Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T1DM For at least 1 year is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day. is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication Exclusion Criteria: has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months history of ketoacidosis in the last 6 months participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]. history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients used a formulation of insulin glargine other than Lantus™ has received injectable incretin-based therapy within the past 8 weeks on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks has undergone bariatric surgery within the past 12 months is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted) has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder has severe peripheral vascular disease has high blood pressure has chronic myopathy, or a progressive neurological or neuromuscular disorder has active nephropathy history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease has human immunodeficiency virus (HIV) has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) history of malignancy in the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer history of melanoma, leukemia, lymphoma, or renal cell carcinoma is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence is pregnant or breast-feeding, or is expecting to conceive or donate eggs has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study has poor mental function or works the night shift
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    29766635
    Citation
    Home PD, Lam RLH, Carofano WL, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rosenstock J, Hollander PA, Gallwitz B. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2220-2228. doi: 10.1111/dom.13354. Epub 2018 Jun 5.
    Results Reference
    derived

    Learn more about this trial

    A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

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