Clinical trial NCT02059187 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: mk-1293, lantus™, prandial insulin
SMILES: [Na+].[Na+].[O-]P([O-])(F)=O
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™