A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus? in Subjects With Type 1 Diabetes Mellitus.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites500 target enrollmentJanuary 10, 2014

ConditionsType 1 Diabetes Mellitus MedDRA version: 16.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsLantus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 500
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 10, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility 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 kg/m2\.
•6\. 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.
•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.

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.