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

• Status: Completed
• Trial end date: 2015-03-11
• Target enrollment: 0
• Participant gender: All

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™.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; MK-1293

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™