A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: MK-1293; Lantus™; Prandial Insulin
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.; 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.; Participants will continue their prandial insulin during the study.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; MK-1293
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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™.
    

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