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OpenTrials
Completed

NCT Number: NCT00330473

A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

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Key information

Conditions

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

Age range

18 year and older

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., Buenos Aires, Argentina

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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
  • Insulin-naive
  • Non-smoker

Exclusion criteria

  • Significant pulmonary, hepatic or renal disease
  • severe congestive heart failure
  • active malignancy or malignancy within the last 5 years
  • systemic glucocorticoid therapy

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)

Other names: LY041001

Insulin

Drug

patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)

Primary outcomes

  1. To assess acceptance of insulin therapy

    Time frame: 9 months

  2. To assess blood sugar control as measured by HbA1c

    Time frame: baseline, 1,3,5,7,9 months

Secondary outcomes

  1. To measure changes in HbA1c over time

    Time frame: baseline, 1,3,5,7,9 months

  2. To assess safety by review of adverse events

    Time frame: throughout study

  3. To assess patient-reported outcomes based on the W-BQ12 questionnaire

    Time frame: screening, baseline, months 5, and 9

  4. To assess patient-reported outcomes based on the DSC-R questionnaire

    Time frame: screening,baseline, months 5 and 9

  5. To assess patient-reported outcomes based on the DTSQ Questionnaire

    Time frame: Screening,baseline, months 5 and 9

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 26, 2006
Registry last updated
Sep 16, 2019

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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