A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
NCT ID: NCT00666718
Last Updated: 2011-05-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
374 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-04-30
Study Completion Date
2010-02-28
Brief Summary
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This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Glargine
Glargine plus Insulin Lispro (2-3 injections)
Group Type
ACTIVE_COMPARATOR
Insulin Glargine
Intervention Type
DRUG
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Insulin Lispro
Intervention Type
DRUG
subcutaneous injections prior to meals, 24 weeks
ILPS
Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)
Group Type
EXPERIMENTAL
Insulin Lispro Protamine Suspension (ILPS)
Intervention Type
DRUG
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Insulin Lispro
Intervention Type
DRUG
subcutaneous injections prior to meals, 24 weeks
Interventions
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Insulin Glargine
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Intervention Type
DRUG
Insulin Lispro Protamine Suspension (ILPS)
patient glucose-level dependent, injection, once daily in the evening, 24 weeks
Intervention Type
DRUG
Insulin Lispro
subcutaneous injections prior to meals, 24 weeks
Intervention Type
DRUG
Other Intervention Names
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LY275585
Eligibility Criteria
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Inclusion Criteria
* Diabetes Mellitus, Type 2
* Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
* Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
* Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2
* Capable and willing to follow the protocol
* Give written consent
* Have a history of severe hypoglycemia in the past 6 months
* Are pregnant or may become pregnant
* Women who are breastfeeding
* Have significant cardiac disease
* Have significant renal or liver disease
* Undergoing therapy for a malignancy
* Contraindications to the study medications
* Have an irregular sleep/wake cycle
* Have a serious disease or any condition considered by the investigator to be exclusionary
* Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
* Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
* Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2
* Capable and willing to follow the protocol
* Give written consent
* Have a history of severe hypoglycemia in the past 6 months
* Are pregnant or may become pregnant
* Women who are breastfeeding
* Have significant cardiac disease
* Have significant renal or liver disease
* Undergoing therapy for a malignancy
* Contraindications to the study medications
* Have an irregular sleep/wake cycle
* Have a serious disease or any condition considered by the investigator to be exclusionary
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
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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Genk, , Belgium
Site Status
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Leuven, , Belgium
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Willebroek, , Belgium
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Holešov, , Czechia
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Hranice I-Mesto, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Bad Mergentheim, , Germany
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Berlin, , Germany
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Damme, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Pirna, , Germany
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Rotenburg-Fulda, , Germany
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Athens, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Ancona, , Italy
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Bari, , Italy
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Milan, , Italy
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Padua, , Italy
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Pistoia, , Italy
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Ravenna, , Italy
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Rome, , Italy
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Gorzów Wielkopolski, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lubin, , Poland
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Mielec, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Baia Mare, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Sf Gheorghe, , Romania
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Modra, , Slovakia
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Nitra, , Slovakia
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Bornova, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Edinburgh, Scotland, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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Rugby, Warwickshire, United Kingdom
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West Bromwich, West Midlands, United Kingdom
Site Status
Countries
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Belgium
Czechia
Germany
Greece
Italy
Poland
Romania
Slovakia
Turkey (Türkiye)
United Kingdom
Other Identifiers
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F3Z-EW-IOPJ
Identifier Type: OTHER
Identifier Source: secondary_id
12047
Identifier Type: -
Identifier Source: org_study_id
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