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A Study on the Effect of 2 Pen Devices on HbA1c

NCT00985712 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2012-06-04

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin Lispro

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

DRUG

Huminsulin Regular

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

DEVICE

HumaPen Memoir

subcutaneously, daily for 24 weeks

DEVICE

HumaPen Luxura

subcutaneously, daily for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985712 on ClinicalTrials.gov