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A Study on the Effect of 2 Pen Devices on HbA1c

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00985712
First received: September 23, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Insulin Lispro
Drug: Huminsulin Regular
Device: HumaPen Memoir
Device: HumaPen Luxura
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 263
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
 Drug: Insulin Lispro
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Other Names:
  • Humalog
  • LY275585
Drug: Huminsulin Regular
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Other Names:
  • Huminsulin Normal
  • LY041001
Device: HumaPen Luxura
subcutaneously, daily for 24 weeks
Experimental: HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
 Drug: Insulin Lispro
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Other Names:
  • Humalog
  • LY275585
Drug: Huminsulin Regular
subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks
Other Names:
  • Huminsulin Normal
  • LY041001
Device: HumaPen Memoir
subcutaneously, daily for 24 weeks

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985712

Locations
Germany
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, 63739
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.
Asslar, Germany, 35614
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Bad Mergentheim, Germany, 97980
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Berlin, Germany, 14089
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Bosenheim, Germany, 55545
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Diez, Germany, 65582
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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Essen, Germany, 45355
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Falkensee, Germany, 14612
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Flensburg, Germany, D-24939
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Frankfurt, Germany, 60388
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Fulda, Germany, 36037
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Giessen, Germany, 35385
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Hamburg, Germany, 21073
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Hannover, Germany, 30173
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Herdecke, Germany, 58313
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Leipzig, Germany, 04103
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Mainz, Germany, 55116
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Münster, Germany, 48153
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Neuwied, Germany, 56564
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Rehlingen-Siersburg, Germany, 66780
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Rotenburg-Fulda, Germany, 36199
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Saarbrücken, Germany, 66121
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Schkeuditz, Germany, 04435
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.
Schwedt/Oder, Germany, 16303
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.
Tuebingen, Germany, 72076
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.
Warburg, Germany, 34414
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, 42283
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00985712     History of Changes
Other Study ID Numbers: 12704, H9D-SB-ITAE
Study First Received: September 23, 2009
Results First Received: May 2, 2012
Last Updated: May 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013