Phase 4
Completed N=20
Comparison of Insulins Aspart and Lispro in Insulin Pumps
Source: ClinicalTrials.gov NCT00461331 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change — 17; 16 Participants — p=0.52
Summary
The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change |
17; 16 | 0.52 |
| SECONDARY Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place |
5.1; 5.6 | 0.15 |
| SECONDARY Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place |
6.9; 6.5 | 0.55 |
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes treated with a pump for at least 3 months
Exclusion Criteria
- Pregnancy
- Plasma Creatinine > 1.2 mg/dl
- Inability to give informed consent
- HbA1c > 8%
- Known or suspected hypersensitivity to trial drugs or any of their components
Data sourced from ClinicalTrials.gov (NCT00461331). 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.