A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00330473
First received: May 24, 2006
Last updated: January 22, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Human Insulin Inhalation Powder Drug: Insulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- To assess acceptance of insulin therapy [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- To assess blood sugar control as measured by HbA1c [ Time Frame: baseline, 1,3,5,7,9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To measure changes in HbA1c over time [ Time Frame: baseline, 1,3,5,7,9 months ] [ Designated as safety issue: No ]
- To assess safety by review of adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- To assess patient-reported outcomes based on the W-BQ12 questionnaire [ Time Frame: screening, baseline, months 5, and 9 ] [ Designated as safety issue: No ]
- To assess patient-reported outcomes based on the DSC-R questionnaire [ Time Frame: screening,baseline, months 5 and 9 ] [ Designated as safety issue: No ]
- To assess patient-reported outcomes based on the DTSQ Questionnaire [ Time Frame: Screening,baseline, months 5 and 9 ] [ Designated as safety issue: No ]
| Enrollment: | 1019 |
| Study Start Date: | June 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
|
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 9 months ( if patient chooses Human Insulin Inhalation Powder option)
Other Name: LY041001
|
|
Active Comparator: 2
Treatment Options available on the market.
|
Drug: Insulin
patient specific dose, oral or injectable, before meals and/or as needed, 9 months. ( patients and investigator determine standard option therapy)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330473
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| Huntington Beach, California, United States, 92646 | |
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| Pomona, California, United States, 91767 | |
| United States, Florida | |
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| Houston, Texas, United States, 77005 | |
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| Spokane, Washington, United States, 99202 | |
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| Tacoma, Washington, United States, 98405 | |
| Argentina | |
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| India | |
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| Chennai, India, 600 013 | |
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| Pune, India, 411007 | |
| Korea, Republic of | |
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| Seoul, Korea, Republic of, 138-736 | |
| Mexico | |
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| Monterrey, Mexico, 64700 | |
| Poland | |
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| Katowice, Poland, 40-044 | |
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| Lublin, Poland, 20-538 | |
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| Warsaw, Poland, 03-242 | |
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| Wroclaw, Poland, 50-127 | |
| Puerto Rico | |
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| Bayamón, Puerto Rico, 00956 | |
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| Carolina, Puerto Rico, 00983 | |
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| Rio Piedras, Puerto Rico, 00921 | |
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| San Juan, Puerto Rico, 00926 | |
| Russian Federation | |
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| Moscow, Russian Federation, 119881 | |
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| Saint Petersburg, Russian Federation, 193257 | |
| South Africa | |
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| Cape Town, South Africa, 7505 | |
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| Pretoria, South Africa, 0143 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00330473 History of Changes |
| Other Study ID Numbers: | 9628, H7U-MC-IDAW |
| Study First Received: | May 24, 2006 |
| Last Updated: | January 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013