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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00487240
Registration number
NCT00487240
Ethics application status
Date submitted
14/06/2007
Date registered
18/06/2007
Date last updated
4/11/2010
Titles & IDs
Public title
Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes
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Scientific title
Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes
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Secondary ID [1]
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F3Z-MC-IOOZ
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Secondary ID [2]
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10937
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Universal Trial Number (UTN)
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Trial acronym
IOOZ
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin Lispro Protamine Suspension
Treatment: Drugs - Insulin Levemir
Experimental: Insulin Lispro Protamine Suspension - Insulin Lispro Protamine Suspension twice daily
Active comparator: Detemir - Insulin Levemir (detemir) subcutaneous (SC) twice daily.
Treatment: Drugs: Insulin Lispro Protamine Suspension
Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
Treatment: Drugs: Insulin Levemir
Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
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Assessment method [1]
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Timepoint [1]
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baseline and 32 weeks
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Secondary outcome [1]
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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
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Assessment method [1]
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The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the "mean change from baseline" is calculated by averaging out for all subjects. \[Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects\]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline.
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Timepoint [1]
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Baseline, 8,16, 24, 32 Weeks
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Secondary outcome [2]
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Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
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Assessment method [2]
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Timepoint [2]
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32 Weeks
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Secondary outcome [3]
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7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
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Assessment method [3]
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Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.
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Timepoint [3]
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32 Weeks
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Secondary outcome [4]
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Glycemic Variability at Endpoint
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Assessment method [4]
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Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose \[SMBG\] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
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Timepoint [4]
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32 Weeks
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Secondary outcome [5]
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Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
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Assessment method [5]
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Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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Timepoint [5]
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Baseline to 32 Weeks
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Secondary outcome [6]
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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
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Assessment method [6]
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Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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Timepoint [6]
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baseline to 32 weeks
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Secondary outcome [7]
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
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Assessment method [7]
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Timepoint [7]
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baseline to 32 weeks
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Secondary outcome [8]
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Change From Baseline in Absolute Body Weight at 32 Week Endpoint
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Assessment method [8]
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Timepoint [8]
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Baseline, 32 Weeks
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Secondary outcome [9]
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Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
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Assessment method [9]
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Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.
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Timepoint [9]
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32 Weeks
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Secondary outcome [10]
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Insulin Dose (Total and By Component [Basal and Bolus])
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Assessment method [10]
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Total daily insulin dose (U/day) was assessed.
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Timepoint [10]
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32 weeks
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Eligibility
Key inclusion criteria
* Clinical diagnosis of type 1 diabetes for one year or more
* Age 18 years or older
* Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
* Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
* As determined by the investigator, are capable and willing to do the following:
* perform self monitoring of blood glucose (SMBG),
* complete patient diaries as required for this protocol,
* use the insulin injection device(s) according to the instructions provided,
* are receptive to diabetes education,
* comply with the required study visits.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
* Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
* Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2008
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Sample size
Target
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Accrual to date
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Final
387
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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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. - Wollongong
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Recruitment hospital [2]
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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. - Box Hill
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Recruitment postcode(s) [1]
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- Wollongong
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Idaho
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Argentina
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State/province [5]
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Buenos Aires
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Country [6]
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Argentina
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State/province [6]
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La Plata
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Country [7]
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Brazil
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State/province [7]
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Fortaleza
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Country [8]
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Brazil
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State/province [8]
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São Paulo
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Country [9]
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Greece
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State/province [9]
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Athens
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Greece
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State/province [10]
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Thessaloniki
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Hungary
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Budapest
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Hungary
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State/province [12]
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Mosonmagyarovar
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Country [13]
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Hungary
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State/province [13]
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Pecs
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Hungary
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State/province [14]
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Szentes
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Hungary
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State/province [15]
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Zalaegerszeg
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Mexico
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Guadalajara
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Mexico
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Pachuca
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Mexico
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State/province [18]
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Puebla
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Romania
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State/province [19]
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Baia Mare
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Iasi
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Country [23]
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Russian Federation
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Arkhangelsk
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Russian Federation
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Moscow
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Russian Federation
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Rostov-On-Don
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Country [26]
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Russian Federation
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State/province [26]
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Saint Petersburg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
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Trial website
https://clinicaltrials.gov/study/NCT00487240
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Trial related presentations / publications
Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J, Chan J; COMPLETE T1D investigators. Comparison of insulin lispro protamine suspension and insulin detemir in basal-bolus therapy in patients with Type 1 diabetes. Diabet Med. 2010 May;27(5):563-9. doi: 10.1111/j.1464-5491.2010.02986.x.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Chacra AR, Kipnes M, Ilag LL, Sarwat S, Giaconia J...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00487240
Download to PDF