A Comparison of LY2605541 versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naive Patients with T2DM not Adequately Controlled with 2 or more Oral Antihyperglycemic Medications
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000801
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Patients with T2DM who are 18 years or older,
treated with at least 2 OAMs for at least 3 months prior to the study and who are insulin naive and have a baseline
HbA1c of 7.0% to 11.0% as determined by the central laboratory at Visit 1 are eligible for this study.
Patients
should not have used insulin therapy in the past 2 years and should not have been treated with glucagon-like
peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months of Visit
1. Patients using DPP-IV inhibitors that are approved for use in combination with insulin are allowed to participate
in the study. Patients using pioglitazone may be allowed to participate depending on restrictions for use in
combination with insulin or metformin described in the local label. Patients should not have had any episodes of
severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to Visit 1.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
- Secondary Outcome Measures
Name Time Method octurnal hypoglycemia rate during 26 weeks of treatment;30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events;Percentage of Participants with HbA1c =6.5% and <7.0%;Fasting Serum Glucose (FSG) (by Laboratory) and Fasting Blood Glucose (FBG) (by Self Monitoring) ;6-Point Self-Monitored Blood Glucose (SMBG) ;Change from Baseline to 26 Weeks in Body Weight