A Study on the Effect of 2 Pen Devices on HbA1c

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Lispro; Drug: Huminsulin Regular; Device: HumaPen Memoir; Device: HumaPen Luxura

• Registration Number: NCT00985712
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Study Start: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-05
• Results First Submitted: 2012-05-02
• Results First Submitted QC: 2012-05-02
• Last Update Submitted: 2012-05-02
• Results First Posted: 2012-06-04
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HumaPen Memoir	Huminsulin Regular	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
HumaPen Memoir	HumaPen Memoir	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
HumaPen Luxura	Insulin Lispro	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
HumaPen Luxura	Huminsulin Regular	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
HumaPen Luxura	HumaPen Luxura	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
HumaPen Memoir	Insulin Lispro	Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint	Baseline, Week 24	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.

Secondary Outcome Measures

Name	Time	Method
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	Week 24	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.
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24	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.
30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24	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.

Trial Locations

Locations (1)

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.; 🇩🇪 Wuppertal, Germany