A study in people with type 2 diabetes to determine how well a meal-time insulin, LY900014, controls diabetes compared to Humalog (insulin lispro) when both are used along with a long-acting insuli

Phase 1

• Conditions: Type II Diabetes Mellitus; MedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-005357-12-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1050

Inclusion Criteria

You can take part in this study if:
· You were diagnosed with type 2 diabetes at least one year ago.
· You are 18 years old or older.
· You are already being treated with insulin allowed for study participation.
· Your blood glucose levels are within allowed limits for study participation.

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 787
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 263

Exclusion Criteria

You cannot take part in this study if:
· You have had emergency treatment for very low blood glucose or poor blood glucose control in the last 6 months.
· You are taking certain diabetes medications that are not allowed for study participation.
· You have major problems with your heart, kidneys, liver, or you have a blood disorder.
You have had or are now being treated for certain types of cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the hypothesis that LY900014 is noninferior to insulin lispro on glycemic control (NIM = 0.4% for HbA1c) in patients with T2D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin glargine or insulin degludec for 26 weeks.;<br> Primary end point(s): Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c<br> ;Secondary Objective: Secondary objectives include testing the hypothesis that LY is superior to insulin lispro in controlling 1 and 2 hour postprandial glucose (PPG) excursions, when administered as prandial insulin. To test the hypothesis that LY is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulin.;Timepoint(s) of evaluation of this end point: 26 weeks