A PHASE III CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OFMK-1293 COMPARED TO LANTUS™ IN SUBJECTS WITH TYPE 2 DIABETESMELLITUS

Not Applicable

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-059-13
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Subject has T2DM with a Visit 1/Screening A1C of <11.0% of and requires insulin for glycemic control (based on ADA/EASD guidelines [5]).
Note: Subjects currently taking any type of basal insulin(s) should require a total daily dose of > 10 units/day. For subjects currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of > 10 units/day.
2. Subject is ears of age on day of signing informed consent.
3. Subject has a body mass index (BMI) <45 kg/m2.
4. Subject is a male, or a female who is highly unlikely to conceive as indicated by meeting at least one of the following criteria:
Subject is not of reproductive potential. A female subject who is not of reproductive potential is defined as one who has either (1) reached natural menopause (defined as ≥ 12 months of spontaneous amenorrhea in women >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.
5. 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.
6. Subject demonstrates compliance with eDiary use as shown by uploading fingerstick glucose values from the study supplied glucose meter daily.

Exclusion Criteria

1. Subject has a history of type 1 diabetes mellitus or a history of ketoacidosis, or subject is assessed by the investigator as possibly having type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L).
Note: Only a subject assessed by the investigator as possibly having type 1 diabetes should have C-peptide measured at Visit 1/Screening.
2. Subject has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months.
3. Subject has a history of intolerance or hypersensitivity to LantusTM or contraindication to LantusTM or one of its excipients based on the label of the country of the investigational site.
Note: Hypoglycemia is not considered a hypersensitivity to LantusTM.
4. Subject received injectable incretin-based therapy (e.g., VictozaTM, ByettaTM) within the prior 8 weeks.
5. 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.
6. Subject has undergone bariatric surgery within 12 months prior to signing the informed consent.
7. 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.
Note: Subjects who did not receive treatment/intervention or participated in non- interventional studies may be enrolled.
8. Subject is likely to require treatment for ≥ 2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids.
Note: Inhaled, nasal, and topical corticosteroids are permitted.
9. Subject has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study.
Note: Subjects who have undergone minor surgery within the prior 4 weeks and are fully recovered or subjects who have planned minor surgery may participate. Minor surgery is defined as a surgical procedure involving local anesthesia.
10. Subject has new or worsening signs or symptoms of coronary heart disease or congestive heart failure (NYHA Class II - IV cardiac status [refer to Appendix 6.5]) 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
11. 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).
12. 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.
Note: Investigators are encouraged to maximize blood pressure control according to current guidelines. Subject may have blood pressure medication adjusted and be enrolled if repeated blood pressure measurement no longer meets exclusion criteria.
13. Subject has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis).
14. Subject has active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).
15. Subject has a medical history of

Study & Design

• Study Type: Interventional
• Study Design: Not specified