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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00377858




Registration number
NCT00377858
Ethics application status
Date submitted
11/09/2006
Date registered
19/09/2006
Date last updated
9/12/2009

Titles & IDs
Public title
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Scientific title
Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections
Secondary ID [1] 0 0
F3Z-MC-IOOX
Secondary ID [2] 0 0
10936
Universal Trial Number (UTN)
Trial acronym
IOOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 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 mid mixture (MM)
Treatment: Drugs - Insulin glargine

Experimental: Insulin Lispro Mid Mixture - Insulin lispro mid mixture (MM) up to three times a day (TID)

Active comparator: Insulin Glargine - Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.


Treatment: Drugs: Insulin lispro mid mixture (MM)
Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

Treatment: Drugs: Insulin glargine
Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Timepoint [1] 0 0
36 weeks
Secondary outcome [1] 0 0
Hemoglobin A1c (HbA1c) at Interval Visits
Timepoint [1] 0 0
12, 24, and 36 weeks
Secondary outcome [2] 0 0
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Timepoint [2] 0 0
12-24-36 weeks
Secondary outcome [3] 0 0
7-point Self-monitored Blood Glucose Profiles
Timepoint [3] 0 0
Baseline, 12-24-36 weeks
Secondary outcome [4] 0 0
Glycemic Variability
Timepoint [4] 0 0
Baseline, 12-24-36 weeks
Secondary outcome [5] 0 0
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Timepoint [5] 0 0
Baseline to 36 Weeks
Secondary outcome [6] 0 0
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Timepoint [6] 0 0
Baseline to 36 Weeks
Secondary outcome [7] 0 0
Number of Patients With at Least One Severe Hypoglycemia Episode
Timepoint [7] 0 0
Baseline to 36 Weeks
Secondary outcome [8] 0 0
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Timepoint [8] 0 0
36 Weeks
Secondary outcome [9] 0 0
Endpoint Insulin Dose; Total, Basal, and Prandial
Timepoint [9] 0 0
36 Weeks
Secondary outcome [10] 0 0
Number of Insulin Injections Per Day
Timepoint [10] 0 0
Weeks 12, 24, 30, 36
Secondary outcome [11] 0 0
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Timepoint [11] 0 0
Baseline, 36 Weeks

Eligibility
Key inclusion criteria
* Have type 2 diabetes
* Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
* Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
* Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
* 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 40 kg/m2.
* Have had more than one episode of severe hypoglycemia in the last24 weeks
* Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
* Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease

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 4
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
484
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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. - Keswick
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. - Fitzroy
Recruitment hospital [3] 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. - Fremantle
Recruitment postcode(s) [1] 0 0
5035 - Keswick
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
Canada
State/province [3] 0 0
Saskatchewan
Country [4] 0 0
France
State/province [4] 0 0
Mantes La Jolie
Country [5] 0 0
France
State/province [5] 0 0
Menton
Country [6] 0 0
France
State/province [6] 0 0
Pau
Country [7] 0 0
France
State/province [7] 0 0
Poitiers
Country [8] 0 0
France
State/province [8] 0 0
Toulouse
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Goyang-Si/Kyunggi-Do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Kwang Ju
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Mexico
State/province [12] 0 0
Chihuahua
Country [13] 0 0
Mexico
State/province [13] 0 0
Guadalajara
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Arkhangelsk
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Moscow
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Saint Petersburg
Country [17] 0 0
Spain
State/province [17] 0 0
Alicante
Country [18] 0 0
Spain
State/province [18] 0 0
Almeria
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Bilbao
Country [21] 0 0
Spain
State/province [21] 0 0
Malaga

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00377858