A Study on the Effect of 2 Pen Devices on HbA1c

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults With Type 1 Diabetes: Novel Pen With Memory Function (HumaPen Memoir) vs. Conventional Pen Without Memory Function (HumaPen Luxura)

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Insulin Lispro
* Drug: Huminsulin Regular
* Device: HumaPen Memoir
* Device: HumaPen Luxura


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HumaPen Luxura<br>Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks | Drug: Insulin Lispro<br>* subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks<br>* Other names: LY275585;Drug: Huminsulin Regular<br>* subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks<br>* Other names: LY041001;Device: HumaPen Luxura<br>* subcutaneously, daily for 24 weeks<br>|
| Experimental: HumaPen Memoir<br>Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks | Drug: Insulin Lispro<br>* subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks<br>* Other names: LY275585;Drug: Huminsulin Regular<br>* subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks<br>* Other names: LY041001;Device: HumaPen Memoir<br>* subcutaneously, daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c. | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint |  | Week 24 | 
| Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint | IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score. | Week 24 | 
| 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24 | Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30. | Baseline through Week 24 | 
| 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24 | Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30. | Baseline through Week 24 |