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 insulin

Protocol I8B-MC-ITRN 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005357-12-ES

Enrollment

1050

Registered

2017-04-04

Start date

2017-06-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Mellitus MedDRA version: 19.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861

Interventions

Product Name: insulin lispro (ultra rapid formulation) Product Code: LY900014 Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN L

Eligibility

Sex/Gender

All

Inclusion criteria

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 536 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 134

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 26 weeks;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.;Primary end point(s): Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c;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.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 26 weeks;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.;Primary end point(s): Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c;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.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Difference between LY900014 and insulin lispro in the 1-hour or 2-hour PPG excursion (serum glucose measured 1 hour or 2 hours after the start of the meal minus fasting serum glucose) from an MMTT at Week 26 2. Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c 3. Rate (events/patient/100 years) of severe hypoglycemic events from baseline through Week 26 4. Rate (events/patient/year and/or events/patient/30 days) and incidence (percent of patients with at least 1 event) of documented symptomatic postmeal hypoglycemia within 1 and 2 hours after start of a meal from baseline through Week 26 5. Rate (events/patient/year and/or events/patient/30 days) and incidence (percent of patients with at least 1 event) of documented symptomatic hypoglycemic events from baseline through Week 26 6. Change from baseline 1,5-AG values at Week 26 7. Change from baseline 10-point SMBG values at Week 26 8. Change from baseline in total, basal and prandial insulin dose at Week 26 9. Change from baseline ITSQ regimen inconvenience and lifestyle flexibility domain scores at Week 26 10. The proportion of patients with HbA1c <7% and =6.5% at Week 26 ;Timepoint(s) of evaluation of this end point: 26 weeks	—

Measure

Time frame

Secondary end point(s): 1. Difference between LY900014 and insulin lispro in the 1-hour or 2-hour PPG excursion (serum glucose measured 1 hour or 2 hours after the start of the meal minus fasting serum glucose) from an MMTT at Week 26 2. Difference between LY900014 and insulin lispro in change from baseline to Week 26 in HbA1c 3. Rate (events/patient/100 years) of severe hypoglycemic events from baseline through Week 26 4. Rate (events/patient/year and/or events/patient/30 days) and incidence (percent of patients with at least 1 event) of documented symptomatic postmeal hypoglycemia within 1 and 2 hours after start of a meal from baseline through Week 26 5. Rate (events/patient/year and/or events/patient/30 days) and incidence (percent of patients with at least 1 event) of documented symptomatic hypoglycemic events from baseline through Week 26 6. Change from baseline 1,5-AG values at Week 26 7. Change from baseline 10-point SMBG values at Week 26 8. Change from baseline in total, basal and prandial insulin dose at Week 26 9. Change from baseline ITSQ regimen inconvenience and lifestyle flexibility domain scores at Week 26 10. The proportion of patients with HbA1c <7% and =6.5% at Week 26 ;Timepoint(s) of evaluation of this end point: 26 weeks

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Countries

Argentina, Australia, Czech Republic, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Puerto Rico, Russian Federation, Slovakia, Spain, Taiwan, United States

Contacts

Public ContactGracia Montes

Lilly S.A.

ensayosclinicos@lilly.com003491623 12 18

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026