Clinical trial NCT02059187: The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)
Official title: A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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™

Primary outcomes:
measure: Change From Baseline in Participant Hemoglobin A1C Level at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline in Participant Body Weight at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24
timeFrame: Up to 24 weeks
measure: Percentage of Participants Experiencing an AE Over the 24-week Treatment Period
timeFrame: Up to 24 weeks
measure: Daily Basal Insulin Dose (Units) at Week 24
timeFrame: Week 24
measure: Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Hemoglobin A1C <7% at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Hemoglobin A1C <6.5% at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hollander PA, Carofano WL, Lam RLH, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rendell MS, Home PD, Gallwitz B, Rosenstock J. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2229-2237. doi: 10.1111/dom.13363. Epub 2018 Jun 10.