A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects with Type 2 Diabetes Mellitus

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects with Type 2 Diabetes Mellitus

Description

This study is to support the development of MK-1293, a proposed follow-on insulin glargine, using Lantus™ (insulin glargine, Sanofi-aventis Pharmaceuticals, Frankfurt, Germany) as the comparator medicinal product. This study will assess the safety and efficacy of MK-1293 compared to Lantus™.

Lead Principal Investigator: Dr. Priscilla Hollander

Baylor Endocrine Center
3600 Gaston Ave.
Dallas, TX 75246

IRB Number: 013-145

Details
Condition Diabetes Mellitus, Type 2, Diabetes Mellitus Types I and II
Clinical Study IdentifierTX138055
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject has T2DM (based on ADA/EASD guidelines [5])
Subject has a Visit 1/Screening A1C of =11.0%
Subject has either
(a) is not currently on insulin but considered to have an indication for insulin treatment with a basal insulin or
(b) is already on a basal insulin (either an intermediate [e.g. NPH], or a long-acting insulin [e.g. Lantus™, Levemir, or Degludec]) or on a premixed insulin regimen for glycemic control
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
Subject is =18 years of age on day of signing informed consent
Subject has a body mass index (BMI) <45 kg/m2
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
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
Subject demonstrates compliance with eDiary use as shown by uploading fingerstick glucose values from the study supplied glucose meter daily

Exclusion Criteria

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
Subject has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months
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]
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
Note: Hypoglycemia is not considered a hypersensitivity reaction to Lantus™
Subject has used a formulation of glargine insulin other than Lantus™. Subjects Requiring Specific Treatments
Subject received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior 8 weeks
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
Subject has undergone bariatric surgery within 12 months prior to signing the informed consent
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 noninterventional studies may be enrolled
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
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
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
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)
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 vto current guidelines. Subject may have blood pressure medication adjusted and be enrolled if repeated blood pressure measurement no longer meets exclusion criteria
Subject has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
Subject has active nephropathy (i.e., nephrotic syndrome or glomerulonephritis)
Subject has a medical history of active liver disease (other than non-alcoholic hepaticsteatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
Subject has human immunodeficiency virus (HIV) as assessed by medical history
Subject has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
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
Note: Subjects with a history of malignancy >5 years prior to signing informed consent should have no evidence of residual or recurrent disease
Subject has a history of melanoma, leukemia, lymphoma, or renal cell carcinoma
Subject is currently being treated for hyperthyroidism
Subject has been on stable dose of thyroid hormone replacement therapy for <6 weeks
Subjects excluded due to TSH criterion may be re-screened after being on a stable thyroid replacement regimen for at least 6 weeks
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