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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
F3Z-MC-IOOZ
Secondary ID [2] 0 0
10937
Universal Trial Number (UTN)
Trial acronym
IOOZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Timepoint [1] 0 0
baseline and 32 weeks
Secondary outcome [1] 0 0
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values - 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.
Timepoint [1] 0 0
Baseline, 8,16, 24, 32 Weeks
Secondary outcome [2] 0 0
Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
Timepoint [2] 0 0
32 Weeks
Secondary outcome [3] 0 0
7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint - 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.
Timepoint [3] 0 0
32 Weeks
Secondary outcome [4] 0 0
Glycemic Variability at Endpoint - 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.
Timepoint [4] 0 0
32 Weeks
Secondary outcome [5] 0 0
Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint - 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.
Timepoint [5] 0 0
Baseline to 32 Weeks
Secondary outcome [6] 0 0
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint - 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.
Timepoint [6] 0 0
baseline to 32 weeks
Secondary outcome [7] 0 0
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Timepoint [7] 0 0
baseline to 32 weeks
Secondary outcome [8] 0 0
Change From Baseline in Absolute Body Weight at 32 Week Endpoint
Timepoint [8] 0 0
Baseline, 32 Weeks
Secondary outcome [9] 0 0
Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) - Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.
Timepoint [9] 0 0
32 Weeks
Secondary outcome [10] 0 0
Insulin Dose (Total and By Component [Basal and Bolus]) - Total daily insulin dose (U/day) was assessed.
Timepoint [10] 0 0
32 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Idaho
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
La Plata
Country [7] 0 0
Brazil
State/province [7] 0 0
Fortaleza
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
Country [10] 0 0
Greece
State/province [10] 0 0
Thessaloniki
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Mosonmagyarovar
Country [13] 0 0
Hungary
State/province [13] 0 0
Pecs
Country [14] 0 0
Hungary
State/province [14] 0 0
Szentes
Country [15] 0 0
Hungary
State/province [15] 0 0
Zalaegerszeg
Country [16] 0 0
Mexico
State/province [16] 0 0
Guadalajara
Country [17] 0 0
Mexico
State/province [17] 0 0
Pachuca
Country [18] 0 0
Mexico
State/province [18] 0 0
Puebla
Country [19] 0 0
Romania
State/province [19] 0 0
Baia Mare
Country [20] 0 0
Romania
State/province [20] 0 0
Brasov
Country [21] 0 0
Romania
State/province [21] 0 0
Bucharest
Country [22] 0 0
Romania
State/province [22] 0 0
Iasi
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Arkhangelsk
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Rostov-On-Don
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Saint Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00487240
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications