EUCTR2015-005356-99-IT
Active, not recruiting
Phase 1
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
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 sites1,392 target enrollmentFebruary 2, 2018
ConditionsType 1 DiabetesMedDRA version: 20.1Level: LLTClassification code 10020639Term: HyperglycemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsHumalog
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Enrollment
- 1392
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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: 1
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 754
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 251
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.
Outcomes
Primary Outcomes
Not specified
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