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

NCT ID: NCT02059187

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 531 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-11
• Study Completion Date: 2015-03-11

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™.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-1293

MK-1293 administered subcutaneously once daily in the evening.

Group Type: EXPERIMENTAL

MK-1293

Intervention Type: DRUG

MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

Prandial insulin

Intervention Type: DRUG

Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

Lantus™

Lantus™ administered subcutaneously once daily in the evening.

Group Type: ACTIVE_COMPARATOR

Lantus™

Intervention Type: DRUG

Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

Prandial insulin

Intervention Type: DRUG

Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

Interventions

MK-1293

MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

Intervention Type: DRUG

Lantus™

Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

Intervention Type: DRUG

Prandial insulin

Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

Intervention Type: DRUG

Other Intervention Names

Insulin glargine [rDNA origin]

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™

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 29761615 (View on PubMed)

Other Identifiers

2012-003478-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293-006

Identifier Type: -

Identifier Source: org_study_id