A Study on the Effect of 2 Pen Devices on HbA1c

NCT ID: NCT00985712

Last Updated: 2012-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HumaPen Luxura

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

Group Type EXPERIMENTAL

Insulin Lispro

Intervention Type DRUG

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

Huminsulin Regular

Intervention Type DRUG

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

HumaPen Luxura

Intervention Type DEVICE

subcutaneously, daily for 24 weeks

HumaPen Memoir

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

Group Type EXPERIMENTAL

Insulin Lispro

Intervention Type DRUG

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

Huminsulin Regular

Intervention Type DRUG

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

HumaPen Memoir

Intervention Type DEVICE

subcutaneously, daily for 24 weeks

Interventions

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Insulin Lispro

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

Intervention Type DRUG

Huminsulin Regular

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

Intervention Type DRUG

HumaPen Memoir

subcutaneously, daily for 24 weeks

Intervention Type DEVICE

HumaPen Luxura

subcutaneously, daily for 24 weeks

Intervention Type DEVICE

Other Intervention Names

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Humalog LY275585 Huminsulin Normal LY041001

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

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Aßlar, , Germany

Site Status

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Bad Mergentheim, , Germany

Site Status

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Berlin, , Germany

Site Status

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Bosenheim, , Germany

Site Status

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Diez, , Germany

Site Status

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Dresden, , Germany

Site Status

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Erlangen, , Germany

Site Status

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Essen, , Germany

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Falkensee, , Germany

Site Status

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Flensburg, , Germany

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Frankfurt, , Germany

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Fulda, , Germany

Site Status

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Giessen, , Germany

Site Status

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Hamburg, , Germany

Site Status

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Hanover, , Germany

Site Status

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Herdecke, , Germany

Site Status

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Leipzig, , Germany

Site Status

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Mainz, , Germany

Site Status

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Münster, , Germany

Site Status

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Neuwied, , Germany

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Rehlingen-Siersburg, , Germany

Site Status

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Rotenburg-Fulda, , Germany

Site Status

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Saarbrücken, , Germany

Site Status

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Schkeuditz, , Germany

Site Status

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Schwedt, , Germany

Site Status

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Tübingen, , Germany

Site Status

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Warburg, , Germany

Site Status

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Wuppertal, , Germany

Site Status

Countries

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Germany

Other Identifiers

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H9D-SB-ITAE

Identifier Type: OTHER

Identifier Source: secondary_id

12704

Identifier Type: -

Identifier Source: org_study_id

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