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OpenTrials
Completed

NCT Number: NCT00231725

Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin

Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily during the trial.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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., Pamplona, Spain

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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 2 Diabetes
  • Already on Lilly insulin or beginning insulin therapy
  • 25 to 75 years old inclusive

Exclusion criteria

  • Currently using, or had used during previous month, oral diabetes medication that is NOT approved for use in combination with insulin in patient's country
  • More than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial

Treatment and study plan

insulin lispro injection [rDNA origin] Low Mix

Drug

Primary outcomes

  1. To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.

Secondary outcomes

  1. To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia

  2. To assess overall patient perception of the device's performance through a patient questionnaire.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Complaints Associated With Use of Pre-Filled Pen B When Used by Patients With Type 2 Diabetes on Twice-Daily Insulin Therapy

Important dates

Study start
2005
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Jun 27, 2007

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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