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

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 16.0Level: 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-CZ
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-21
• Last Update Posted: 19 September 2016

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