A study in people with type 1 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 insulin.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2015-005356-99-AT
• Date of registration: 21/04/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study in people with type 1 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 insulin.
• Scientific title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro with an Open-Label Postprandial LY900014 Treatment Group, in Combination with Insulin Glargine or Insulin Degludec, in Adults with Type 1 Diabetes - PRONTO-T1D
• Date of first enrolment: 30/05/2017
• Target sample size: 1567
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005356-99
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: one arm is open label; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Brazil, Germany, Greece, India, Italy, Japan, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
•   You were diagnosed with type 1 diabetes at least one year ago.
•   You are 18 years old or older.
•   You are already using a long-acting insulin and rapid-acting insulin analog.
•   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 1175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 392

Exclusion criteria:
•   You have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
•   You have had more than 1 emergency treatment for poor 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 that prevents you from study participation.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 1 Diabetes
MedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Product Name: Insulin lispro (ultra rapid formulation)
Product Code: LY900014
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Humalog
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 26 weeks

Primary end point(s): Change in HbA1c

Secondary Objective: To test the hypothesis that LY900014 is superior to insulin lispro in controlling 1-hour PPG excursions, when administered as prandial insulin.
To test the hypothesis that LY900014 is superior to insulin lispro in controlling 2-hour PPG excursions, when administered as prandial insulin. 
To test the hypothesis that LY900014 is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulin.
To test the hypothesis that LY900014 administered as postprandial insulin 20 minutes after the start of a meal, (LY900014+20), is noninferior to insulin lispro, administered as prandial insulin, on glycemic control (NIM=0.4% for HbA1c)

Main Objective: To test the hypothesis that LY900014 is noninferior to insulin lispro on glycemic control (non-inferiority margin [NIM]=0.4% for hemoglobin A1c [HbA1c]) in patients with T1D, 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

Secondary Outcome(s)

Secondary end point(s): 1.       Difference between LY900014 and insulin lispro in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT.
2.       Difference between LY900014 and insulin lispro in the 2-hour PPG excursion (serum glucose measured 2 hours after the start of the meal minus fasting serum glucose) from an MMTT.
3.       Difference between LY900014 and insulin lispro in change from baseline in HbA1c 
4.       Difference between LY900014+20 and insulin lispro in change from baseline in HbA1c

Timepoint(s) of evaluation of this end point: 1. 26 weeks
2. 26 weeks
3. 26 weeks
4. 26 weeks

Secondary ID(s)

2015-005356-99-SE

I8B-MC-ITRM

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date:
Contact: