Phase 1
Completed N=28
A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02152384 ↗
Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Mar 2019
Primary outcomePrimary: Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro — 677.84; 716.52; 572.96; 506.22 mg*h/dL
Summary
This study will look into how a base dose of insulin peglispro and insulin glargine will affect the meal time dose and efficacy of insulin lispro in type 1 diabetics.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro |
677.84; 716.52; 572.96; 506.22; 393.28; 369.08 | — |
| SECONDARY Pharmacokinetics (PK): Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro |
850; 852 | — |
| SECONDARY Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value) |
52.756; 56.321; 13.908; 18.765 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Last Time (AUC [0 Tlast]) for Paracetamol |
33400; 33600 | — |
| SECONDARY Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29 |
27.1; 32.1; 53.8; 58.9; 32.5; 37.7 | — |
| SECONDARY Pharmacodynamics (PD): Area Under the Concentration Zero Through 5 Hours (AUC 0-5h) for Triglycerides |
6.85; 6.01 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp |
243; 222; 926; 897 | — |
Eligibility Criteria
Inclusion Criteria
- Have a stable (within 0.5 percent (%) from last measure) glycated hemoglobin (HbA1c) 500 milliseconds (ms) or have any other abnormality in the 12 lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have an abnormal blood pressure as determined by the investigator
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus [T1DM]), hematological, or neurological disorders
- Have fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 micromoles per liter [mmol/L])
- Have used systemic corticosteroids within 4 weeks prior to randomization
- Currently receive insulin pump or insulin degludec
- Have poorly controlled diabetes or are known to have poor awareness of hypoglycemia
- Have history of gastroparesis or gastrointestinal malabsorption
- Require treatment with any drug other than insulin to treat diabetes
- Have a previous history of proliferative retinopathy
Data sourced from ClinicalTrials.gov (NCT02152384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.