The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

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™