A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

NCT ID: NCT02059161

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-17
• Study Completion Date: 2015-11-12

Brief Summary

The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™.

Conditions

Type 1 Diabetes Mellitus

Study Design

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

Study Groups

MK-1293

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

Group Type: EXPERIMENTAL

MK-1293

Intervention Type: DRUG

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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 will continue their prandial insulin during the study.

Lantus

Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

Group Type: ACTIVE_COMPARATOR

Lantus™

Intervention Type: DRUG

Lantus™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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 will continue their prandial insulin during the study.

Interventions

MK-1293

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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 will continue their prandial insulin during the study.

Intervention Type: DRUG

Other Intervention Names

Insulin glargine

Eligibility Criteria

Inclusion Criteria

• T1DM For at least 1 year
• is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of >=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of >=10 units/day.
• is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication

Exclusion Criteria

• has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months
• history of ketoacidosis in the last 6 months
• 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].
• history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients
• used a formulation of insulin glargine other than Lantus™
• has received injectable incretin-based therapy within the past 8 weeks
• on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks
• has undergone bariatric surgery within the past 12 months
• is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted)
• has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study
• has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder
• has severe peripheral vascular disease
• has high blood pressure
• has chronic myopathy, or a progressive neurological or neuromuscular disorder
• has 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
• has human immunodeficiency virus (HIV)
• has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
• history of malignancy in the past 5 years, 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
• is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks
• is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
• is pregnant or breast-feeding, or is expecting to conceive or donate eggs
• has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study
• has poor mental function or works the night shift

• 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

Home PD, Lam RLH, Carofano WL, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rosenstock J, Hollander PA, Gallwitz B. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2220-2228. doi: 10.1111/dom.13354. Epub 2018 Jun 5.

Reference Type: DERIVED

PMID: 29766635 (View on PubMed)

Other Identifiers

2011-003971-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293-003

Identifier Type: -

Identifier Source: org_study_id