the safety and efficacy of mk-1293 versus lantus™ in participants with type 2 diabetes mellitus (mk-1293-006)

Conditions: Type 2 Diabetes Mellitus

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™