A Study on the Effect of 2 Pen Devices on HbA1c

Eli Lilly and Company263 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

263

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin LisproDRUG

subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks

Huminsulin RegularDRUG

subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks

HumaPen MemoirDEVICE

subcutaneously, daily for 24 weeks

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline through Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aschaffenburg, Germany

Aßlar, Germany

Bad Mergentheim, Germany

Berlin, Germany

Bosenheim, Germany

Diez, Germany

Dresden, Germany

Erlangen, Germany

Essen, Germany

Falkensee, Germany

...and 19 more locations