The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-1293; Lantus™; Prandial insulin
Intervention description: MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.; Lantus™ (insulin glargine [rDNA origin]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.; Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.
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: 531.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants
      with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean
      change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in
      participants treated with MK-1293 compared with that in participants treated with Lantus™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes
             Association (ADA) or the European Association for the Study of Diabetes (EASD)

          -  hemoglobin A1C of ≤11.0% and requires insulin for glycemic control

          -  Body mass index (BMI) <45 kg/m^2

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis, or has type 1
             diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L)

          -  One or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas
             or unconsciousness within the past 6 months

          -  History of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™
             or one of its excipients based on the label of the country of the investigational site

          -  On a weight loss program within the last 8 weeks

          -  Received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior
             8 weeks

          -  Bariatric surgery within 12 months prior to signing the informed consent

          -  Likely to require treatment for ≥2 consecutive weeks or repeated courses of
             corticosteroids

          -  Undergone a surgical procedure within 4 weeks prior to signing informed consent or has
             planned major surgery during the study

          -  New or worsening signs or symptoms of coronary heart disease or congestive heart
             failure within the last 3 months

          -  Presence of any of the following during the last 3 months: acute coronary syndrome,
             coronary artery intervention, and/or stroke or transient ischemic neurological
             disorder

          -  Severe peripheral vascular disease

          -  Systolic blood pressure ≥ 160 mm Hg or a diastolic ≥95 mm Hg and blood pressure is not
             considered likely to be under these limits with an adjustment in antihypertensive
             medication

          -  Chronic myopathy or a progressive neurological or neuromuscular disorder

          -  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

          -  Human immunodeficiency virus (HIV)

          -  Clinically important hematological disorder (such as aplastic anemia,
             myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

          -  History of malignancy ≤5 years prior to signing informed consent, 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

          -  Hyperthyroidism

          -  On a stable dose of thyroid hormone replacement therapy for <6 weeks

          -  Uses recreational or illicit drugs or has had a recent history (within the last year)
             of drug or alcohol abuse or dependence

          -  Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the
             study, including 14 days following the last dose of study drug

          -  Donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing
             informed consent, or intends to donate blood products within the projected duration of
             the study

          -  Poor mental function or any other reason to expect that the participant may have
             difficulty in complying with the requirements of the study

          -  Clinically significant ECG abnormality which exposes the participant to risk by
             enrolling in the study

          -  Positive urine pregnancy test

          -  Participant is a night shift worker which causes difficulty complying with the
             overnight fast requirement and has potential for confounding the 7-point SMBG analysis

          -  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]

          -  Has used a formulation of glargine insulin other than Lantus™