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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01468987




Registration number
NCT01468987
Ethics application status
Date submitted
8/11/2011
Date registered
10/11/2011
Date last updated
17/04/2018

Titles & IDs
Public title
A Study in Participants With Type 2 Diabetes Mellitus
Scientific title
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study
Secondary ID [1] 0 0
I2R-MC-BIAM
Secondary ID [2] 0 0
12145
Universal Trial Number (UTN)
Trial acronym
IMAGINE 4
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
Active comparator: Insulin Glargine + Insulin Lispro - Participant-specific dose of Insulin Glargine will be administered subcutaneously (SC) once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro will be administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

Experimental: LY2605541 + Insulin Lispro - Participant-specific dose of LY2605541 will be administered SC once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro will be administered SC for preprandial and supplemental doses for 26 weeks.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
Timepoint [1] 0 0
Baseline, 26 weeks
Secondary outcome [1] 0 0
Total Hypoglycemia Rates (Adjusted for 30 Days)
Timepoint [1] 0 0
Baseline through 26 weeks
Secondary outcome [2] 0 0
Percentage of Participants With Total Hypoglycemia Episodes
Timepoint [2] 0 0
Baseline through 26 weeks
Secondary outcome [3] 0 0
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
Timepoint [3] 0 0
Baseline through 26 weeks
Secondary outcome [4] 0 0
Percentage of Participants With Nocturnal Hypoglycemia Episodes
Timepoint [4] 0 0
Baseline through 26 weeks
Secondary outcome [5] 0 0
Body Weight Change From Baseline to 26 Weeks
Timepoint [5] 0 0
Baseline, 26 weeks
Secondary outcome [6] 0 0
Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
Timepoint [6] 0 0
26 weeks
Secondary outcome [7] 0 0
Percentage of Participants With HbA1c <7.0% and =6.5% at 26 Weeks
Timepoint [7] 0 0
up to 26 weeks
Secondary outcome [8] 0 0
Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
Timepoint [8] 0 0
up to 26 weeks
Secondary outcome [9] 0 0
Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
Timepoint [9] 0 0
26 weeks
Secondary outcome [10] 0 0
Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
Timepoint [10] 0 0
26 weeks
Secondary outcome [11] 0 0
Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
Timepoint [11] 0 0
26 weeks
Secondary outcome [12] 0 0
0300-hour Blood Glucose to FBG Excursion at 26 Weeks
Timepoint [12] 0 0
26 weeks
Secondary outcome [13] 0 0
HbA1c at 26 Weeks
Timepoint [13] 0 0
26 weeks
Secondary outcome [14] 0 0
Lipid Profile at 26 Weeks
Timepoint [14] 0 0
26 weeks
Secondary outcome [15] 0 0
Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
Timepoint [15] 0 0
Baseline through 26 weeks
Secondary outcome [16] 0 0
Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
Timepoint [16] 0 0
up to 26 weeks
Secondary outcome [17] 0 0
Low Blood Sugar Survey (LBSS) at 26 Weeks
Timepoint [17] 0 0
26 weeks
Secondary outcome [18] 0 0
EuroQoL-5D (EQ-5D) at 26 Weeks
Timepoint [18] 0 0
up to 26 weeks
Secondary outcome [19] 0 0
Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
Timepoint [19] 0 0
up to 26 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

* Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
* Had diabetes =1 year
* Have a hemoglobin A1c (HbA1c) value =7.0% and <12.0% at screening
* Have a body mass index (BMI) =45.0 kilograms per square meter (kg/m^2)
* Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
* This inclusion criterion applies ONLY to women of childbearing potential

* Are not breastfeeding
* Test negative for pregnancy at screening and randomization
* Do not intend to become pregnant during the study
* Have practiced a reliable method of birth control for at least 6 weeks prior to screening
* Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
* Have access to a method of communication with the site
* Have refrigeration in the home
* Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
* Have given written informed consent to participate in this study in accordance with local regulations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Continuous subcutaneous insulin infusion therapy prior to screening
* Are using twice daily insulin glargine prior to screening
* Excessive insulin resistance defined as having received a daily dose of insulin =2.0 units per kilogram (units/kg) at the time of pre-randomization
* Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
* Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for =90 days prior to screening
* Have fasting hypertriglyceridemia (defined as >4.5 millimoles per liter [mmol/L], >400 milligrams per deciliter [mg/dL]) at screening
* Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Are currently receiving renal dialysis or have a serum creatinine =2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD], acute or chronic hepatitis, non-alcoholic steatohepatitis [NASH], or elevated liver enzyme measurements as indicated below:

* total bilirubin =2X the upper limit of normal (ULN) as defined by the central laboratory, or
* alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.5X ULN as defined by the central laboratory, or
* aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) >2.5X ULN as defined by the central laboratory
* Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
* Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
* Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
* Have had an organ transplant
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
1369
Recruitment in Australia
Recruitment state(s)
NSW,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. - Camperdown
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. - St Leonards
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. - Daw Park
Recruitment hospital [4] 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. - East Ringwood
Recruitment hospital [5] 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. - Geelong
Recruitment hospital [6] 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. - Parkville
Recruitment hospital [7] 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
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
3135 - East Ringwood
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
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Istanbul
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Kayseri
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Turkey
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Kutahya
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Cleveland
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Leicestershire
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Scotland
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United Kingdom
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Surrey

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/NCT01468987