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OpenTrials
Completed

NCT Number: NCT00985712

A Study on the Effect of 2 Pen Devices on HbA1c

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Lispro

Drug

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

Other names: Humalog, LY275585

Huminsulin Regular

Drug

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

Other names: Huminsulin Normal, LY041001

HumaPen Memoir

Device

subcutaneously, daily for 24 weeks

HumaPen Luxura

Device

subcutaneously, daily for 24 weeks

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint

    Time frame: 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 outcomes

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

    Time frame: Week 24

  2. Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint

    Time frame: 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.

  3. 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24

    Time frame: 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.

  4. 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 28, 2009
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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