A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:July 14, 2017
End Date:March 4, 2019

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A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with
insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).


Inclusion Criteria:

- Have been diagnosed (clinically) with T2D, based on the World Health Organization
(WHO) classification for at least 1 year prior to screening.

- Have been treated for at least 90 days prior to screening with:

- Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300,
insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn
[NPH] insulin) in combination with at least 1 prandial injection of bolus insulin
(insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular
insulin) Or

- Premixed analog or human insulin regimens with any basal and bolus insulin
combination injected at least twice daily

- Participants may be treated with up to 3 of the following oral antihyperglycemic
medications (OAMs) in accordance with local regulations:

- Metformin

- Dipeptidyl peptidase-4 (DPP-4) inhibitor

- Sodium glucose cotransporter 2 (SGLT2) inhibitor

- Sulfonylurea

- Meglitinide

- Alpha-glucoside inhibitor

- Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at
the time of screening.

- Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

Exclusion Criteria:

- Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune
Diabetes in Adults.

- Have hypoglycemia unawareness as judged by the investigator.

- Have had any episode of severe hypoglycemia within the 6 months prior to screening.

- Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar
state within the 6 months prior to screening.

- Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or
pramlintide within 90 days prior to screening.
We found this trial at
3
sites
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: David Robbins
Phone: 913-588-2097
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Columbus, Ohio 43213
Principal Investigator: S Arora
Phone: 614-501-6164
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Columbus, OH
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