A 6-month study to compare a new long-acting insulin and Human Insulin NPH in Patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 14.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-003941-13-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 630

Inclusion Criteria

Have had T2DM for at least 1 year not treated with insulin
Are 18 years of age or older
Have been receiving 2 or more OAMs for at least 3 months prior to the study
Have HbA1c of 7.0% to 11.0%
Have BMI =45.0% kg/m2
Are willing and able to inject insulin and perform self-monitoring blood glucose
Have given written informed consent to participate in this study
Are not pregnant or breastfeeding (only applies to females of child-bearing potential)

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 470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Have used insulin therapy in the past 2 years
Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months of Visit 1.
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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is noninferior to human insulin NPH for change in hemoglobin A1c (HbA1c) from baseline to 26 weeks ;Secondary Objective: to demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is superior to human insulin NPH (26 weeks) for:<br>1.Nocturnal hypoglycemia rate <br>2.Total hypoglycemia rate <br>3.Proportion of patients with HbA1c <7.0% and no nocturnal hypoglycemia <br>4.HbA1c change from baseline <br>5.Proportion of patients with HbA1c <7% <br>6.Fasting serum glucose (FSG) by laboratory measurement <br>;Primary end point(s): Change in HbA1c from baseline using pooled data from LY2605541 treatment groups compared to human insulin NPH;Timepoint(s) of evaluation of this end point: Week 26

Secondary Outcome Measures