Active not recruiting

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

I8B-FH-ITSE - ClinicalTrials.gov - NCT03952143

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).
How long will I be in the trial?
The study will last about 39 weeks and may include up to 19 visits.
Email
Active not recruiting

A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

I8B-FH-ITSE - ClinicalTrials.gov - NCT03952143

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).
How long will I be in the trial?
The study will last about 39 weeks and may include up to 19 visits.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification

Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily

Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs)

Participants must have a HbA1c ≥7.0% and ≤11.0%

Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2)

Participants must NOT

Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults

Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening

Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening

Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec

Could I receive a Placebo?

no

Enrollment Goal

564

Trial Dates

May 2019 - February 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification

Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily

Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs)

Participants must have a HbA1c ≥7.0% and ≤11.0%

Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2)

Participants must NOT

Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults

Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening

Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening

Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening

Trial Summary

Conditions the trial is for

Adult Type 2 Diabetes

What the trial is testing?

LY900014, Insulin Lispro, Insulin Glargine, Insulin Degludec

Could I receive a Placebo?

no

Enrollment Goal

564

Trial Dates

May 2019 - February 2021

Trial Phase

3

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Trial Locations

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Adult Type 2 Diabetes Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?