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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
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
Trial website
https://clinicaltrials.gov/study/NCT00377858
Trial related presentations / publications
Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00377858