Type 1 Diabetes Mellitus MedDRA version: 16.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: MK-1293
Product Code: MK-1293
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: MK-1293
Concent
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has had T1DM for at least one year prior to Visit 1 and has a Visit 1 C-peptide ?0.7 ng/mL (0.23 nmol/L) when plasma glucose is >90 mg/dL (5 mmol/L). 2. Subject currently on a regimen of basal insulin and has been using rDNA origin prandial insulin (i.e. lispro, aspart, glulisine) for a total duration of ?4 weeks. 3. Subject is ?18 years of age on day of signing informed consent. 4. Subject has a Visit 1/Screening A1C of ?11.0%. 5. Subject has a body mass index (BMI) 45 years of age, or ?6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory), or (2) had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening. -Subject is of reproductive potential and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication. Acceptable methods of birth control are: hormonal contraception, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. 7. Subject understands the study procedures; alternative treatments available, risks involved with the study, and voluntarily agree to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 8. Subject demonstrates compliance with eDiary use as shown by uploading fingerstick glucose values from the study supplied glucose meter daily. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. Subject has had one or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months. 2. Subject has a history of ketoacidosis in the last 6 months. 3. Subject, 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]. 4. Subject has a 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. 5. Subject has used a formulation of insulin glargine other than Lantus?. 6. Subject received injectable incretin-based therapy (e.g., Victoza?, Byetta?) within the prior 8 weeks. 7. Subject is on a weight loss program and not in the maintenance phase, or has started a weight loss medication (such as orlistat) within the prior 8 weeks. 8. Subject has undergone bariatric surgery within 12 months prior to signing the informed consent. 9. Subject is currently participating in, or has participated in a study with an investigational compound or device within the prior 12 weeks of signing informed consent or is not willing to refrain from participating in another study. 10. Subject is likely to require treatment for ?2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids. 11. Subject has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study. 12. Subject has new or worsening signs or symptoms of coronary heart disease or congestive heart failure (NYHA Class II - IV cardiac status) within the past 3 months, or has any of the following disorders within the past 3 months: Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention (e.g., CABG or PTCA), Stroke or transient ischemic neurological disorder. 13. Subject has severe peripheral vascular disease (e.g., claudication with minimal activity, a non-healing ischemic ulcer, or disease which is likely to require surgery or angioplasty). 14. Subject has a systolic blood pressure ?160 mm Hg or a diastolic ?95 mm Hg and blood pressure is not considered likely to be under these limits at Visit 2/Day 1 with an adjustment in antihypertensive medication. 15. Subject has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis). 16. Subject has active nephropathy (i.e., nephrotic syndrome or glomerulonephritis). 17. Subject has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease. 18. Subject has human immunodeficiency virus (HIV) as assessed by medical history. 19. Subject has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). 20. Subject has a 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. 21. Subject has a history of melanoma, leukemia, lymphoma, or renal cell carcinoma. 22. Subject is currently being treated for hyperthyroidism. 23. Subject has been on stable dose of thyroid hormone replacement therapy for <6 weeks. 24. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the effect of treatment with MK-1293 compared with Lantus? on anti-insulin antibody development after 24 weeks of treatment. 2. To assess the non-inferiority of treatment with MK-1293 compared with Lantus? on A1C after 24 weeks of treatment.;Secondary Objective: 1. To assess the equivalence of treatment with MK-1293 compared with Lantus? on A1C after 24 weeks of treatment. 2. To assess the effect of treatment with MK-1293 compared with Lantus? on anti-insulin antibody development after 52 weeks of treatment. 3. To assess the effect of treatment with MK-1293 compared with Lantus? on A1C after 52 weeks of treatment. 4. To assess the safety and tolerability, including body weight, hypoglycemia and adverse events, of MK-1293 compared to Lantus? after 24 and 52 weeks of treatment. 5. To assess the effect of treatment with MK-1293 compared with Lantus? on insulin dose (units) (total and by component [basal and bolus]) and insulin dose per body weight unit (unit/kg) (total and by component [basal and bolus]) after 24 and 52 weeks of treatment. 6. To assess the effect of treatment with MK-1293 compared with Lantus? on fasting plasma glucose and 7-point self-monitored blood glucose (SMBG) profiles after 24 and 52 weeks of treatment.;Primary end point(s): -Change from baseline in A1C at Week 24 -Proportions of subjects with any confirmed positive Anti-Insulin Antibody (AIA) (including baseline) up through Week 24. -Proportion of subjects who have negative AIA at baseline but develop confirmed positive AIA at any time up through Week 24. -Changes from baseline in AIA titers after 24 weeks of treatment. -Proportion of subjects with any insulin neutralizing antibodies (based on the subjects who have confirmed positive AIA at the corresponding time point) up through 24 weeks of treatment (including baseline);Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 24 and week 52;Secondary end point(s): -Change from baseline in A1C at Week 52 -Insulin dose (total and by component [basal and bolus]) at Week 24 and Week 52 -Insulin dose per kg of body weight (unit/kg) (total and by component [basal and bolus]) at Week 24 and Week 52 -Change from baseline in fasting plasma glucose (FPG) at Week 24 and Week 52 -Change from baseline in 7-point SMBG (7-point average) at Week 24 and Week 52 -Proportion of subjects attaining A1C glycemic goals of <7% and <6.5% after 24 and 52 weeks of treatment | — |
Countries
Australia, Colombia, Mexico, New Zealand, Peru, South Africa, Spain, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed