Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
426 participants
INTERVENTIONAL
2007-11-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin lispro low mixture
Insulin lispro low mixture (1, 2 or 3 daily injections)
Insulin lispro low mixture
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
Insulin glargine
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
Insulin glargine
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
Insulin lispro
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Interventions
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Insulin lispro low mixture
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.
Insulin glargine
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks
Insulin lispro
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
* Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
* Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
* Able to perform self monitoring of blood glucose
Exclusion Criteria
* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
* Have a body mass index greater than 35 kg/m2
* History or presence of kidney disease
* Have cardiac disease (Class III or IV)
30 Years
79 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
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.
Daw Park, South Australia, Australia
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East Ringwood, Victoria, Australia
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Nedlands, Western Australia, Australia
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Belém, , Brazil
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Campinas, , Brazil
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Mississauga, Ontario, Canada
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Ottawa, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Sherbrooke, Quebec, Canada
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Beijing, , China
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Guangzhou, , China
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Shanghai, , China
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Aligarh, , India
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Bangalore, , India
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Coimbatore, , India
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Mumbai, , India
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Trivandrum, , India
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Mexico City, , Mexico
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Monterrey, , Mexico
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Kyunggi-Do, , South Korea
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Seoul, , South Korea
Countries
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References
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Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012 Sep;29(9):e263-72. doi: 10.1111/j.1464-5491.2012.03722.x.
Other Identifiers
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F3Z-CR-IOPH
Identifier Type: OTHER
Identifier Source: secondary_id
11541
Identifier Type: -
Identifier Source: org_study_id