NCT00985712|CompletedPhase 4Results

A Study on the Effect of 2 Pen Devices on HbA1c

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)

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

12704H9D-SB-ITAE

Study Type

interventional

Target

263

Locations

1 country

Sites

Timeline

RegisteredSep 2009

StartedOct 2009

CompletionJul 2011

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

263

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Oct 2009

Geographic Reach

1 country

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

September 23, 2009

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed

3 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

11 months until next milestone

Results Posted

Study results publicly available

June 4, 2012

Completed

Last Updated

June 4, 2012

Status Verified

May 1, 2012

Enrollment Period

1.7 years

First QC Date

September 23, 2009

Results QC Date

May 2, 2012

Last Update Submit

May 2, 2012

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

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

Study Arms (2)

HumaPen Luxura

EXPERIMENTAL

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

Drug: Insulin LisproDrug: Huminsulin RegularDevice: HumaPen Luxura

HumaPen Memoir

EXPERIMENTAL

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

Drug: Insulin LisproDrug: Huminsulin RegularDevice: HumaPen Memoir

Interventions

Insulin LisproDRUG

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

Also known as: Humalog, LY275585

HumaPen LuxuraHumaPen Memoir

Huminsulin RegularDRUG

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

Also known as: Huminsulin Normal, LY041001

HumaPen LuxuraHumaPen Memoir

HumaPen MemoirDEVICE

subcutaneously, daily for 24 weeks

HumaPen Memoir

HumaPen LuxuraDEVICE

subcutaneously, daily for 24 weeks

HumaPen Luxura

Eligibility Criteria

Age8 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes mellitus
receiving at least 3 prandial injections per day with short-acting or analogue insulin

You may not qualify if:

Insulin pump therapy
receiving pre-mixed insulin preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (29)

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, 63739, Germany

Location

Aßlar, 35614, Germany

Location

Bad Mergentheim, 97980, Germany

Location

Berlin, 14089, Germany

Location

Bosenheim, 55545, Germany

Location

Diez, 65582, Germany

Location

Dresden, 01307, Germany

Location

Erlangen, 91054, Germany

Location

Essen, 45355, Germany

Location

Falkensee, 14612, Germany

Location

Flensburg, D-24939, Germany

Location

Frankfurt, 60388, Germany

Location

Fulda, 36037, Germany

Location

Giessen, 35385, Germany

Location

Hamburg, 21073, Germany

Location

Hanover, 30173, Germany

Location

Herdecke, 58313, Germany

Location

Leipzig, 04103, Germany

Location

Mainz, 55116, Germany

Location

Münster, 48153, Germany

Location

Neuwied, 56564, Germany

Location

Rehlingen-Siersburg, 66780, Germany

Location

Rotenburg-Fulda, 36199, Germany

Location

Saarbrücken, 66121, Germany

Location

Schkeuditz, 04435, Germany

Location

Schwedt, 16303, Germany

Location

Tübingen, 72076, Germany

Location

Warburg, 34414, Germany

Location

Wuppertal, 42283, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 28, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 4, 2012

Results First Posted

June 4, 2012

Record last verified: 2012-05

Locations

DE(29)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

HumaPen Luxura

HumaPen Memoir

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations