Phase 4
Completed N=263
A Study on the Effect of 2 Pen Devices on HbA1c
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00985712 ↗
Enrolled (actual)
263
Serious AEs
5.8%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint — -0.48; -0.43 percentage of glycosylated hemoglobin — p=0.6692
Summary
The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint |
-0.48; -0.43 | 0.6692 |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint |
5.5; 3.1; 16.5; 11.0 | 0.3551 |
| SECONDARY Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint |
4.06; 4.05 | 0.9070 |
| SECONDARY 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24 |
2.68; 2.46 | 0.9817 |
| SECONDARY 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24 |
2.56; 3.92 | 0.1187 |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus
- receiving at least 3 prandial injections per day with short-acting or analogue insulin
Exclusion Criteria
- Insulin pump therapy
- receiving pre-mixed insulin preparations
Data sourced from ClinicalTrials.gov (NCT00985712). 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.