Diabetes Mellitus, Type 2Phase 3IMAGINE 4NCT01468987

A Study in Participants With Type 2 Diabetes Mellitus

A Phase 3 study testing LY2605541, Insulin Glargine and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 156 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is: To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2605541, Insulin Glargine and Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,369 participants
Where: 156 sitesin 25 countries
Study dates: Dec 2011to Aug 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

156 sites in 25 countries.

Country

City, postcode or hospital

156 sites in 25 countries

United States48 sites

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Anaheim, California, 92801
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Arlington, Texas, 76014
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Atlanta, Georgia, 30308
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Austin, Texas, 78731
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Baltimore, Maryland, 21204
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Bangor, Maine, 04401
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Billings, Montana, 59101
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Chattanooga, Tennessee, 37411
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Chino, California, 91710
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Cleveland, Ohio, 44122
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Columbus, Ohio, 43213
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Concord, California, 94520
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Dallas, Texas, 75231
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Daytona Beach, Florida, 32117
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Des Moines, Iowa, 50314
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Eagan, Minnesota, 55123
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Fargo, North Dakota, 58103
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Fresno, California, 93720
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Greer, South Carolina, 29651
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32204
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Jefferson City, Missouri, 65109
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La Mesa, California, 91942
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Lancaster, California, 93534
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Las Vegas, Nevada, 89148
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Lexington, Kentucky, 40503
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Little Rock, Arkansas, 72205
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Longmont, Colorado, 80501
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Memphis, Tennessee, 38119
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Mentor, Ohio, 44060
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Mission Hills, California, 91345
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Mobile, Alabama, 36617
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Morehead City, North Carolina, 28557
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Nashua, New Hampshire, 03063
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New York, New York, 10025
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Omaha, Nebraska, 68114
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Pittsburgh, Pennsylvania, 15224
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Renton, Washington, 98057
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Spokane, Washington, 99202
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Springfield, Illinois, 62704
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St Louis, Missouri, 63141
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Tacoma, Washington, 98405
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Toms River, New Jersey, 08753
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Topeka, Kansas, 66606
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Tucson, Arizona, 85724
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Tustin, California, 92780
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West Palm Beach, Florida, 33401
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Winter Haven, Florida, 33880

Other trials in United States

Germany9 sites

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Berlin, 10409
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Burghausen, 84489
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Eisenach, 99817
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Essen, 45355
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Falkensee, 14612
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Mainz, 55116
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Mayen, 56727
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Münster, 48153
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Neuwied, 56564

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Australia7 sites

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Camperdown, New South Wales, 2050
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Daw Park, South Australia, 5041
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East Ringwood, Victoria, 3135
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Fremantle, Western Australia, 6160
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Geelong, Victoria, 3220
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065

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Croatia6 sites

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Čakovec, 40000
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Osijek, 31000
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Rijeka, HR-51000
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Slavonski Brod, 35000
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Varaždin, 42000
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Zagreb, 10000

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Israel6 sites

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Beersheba, 84101
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Holon, 58100
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Jerusalem, 91120
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Nahariya, 22100
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Safed, 13110
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Tel HaShomer, 52621

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Czechia5 sites

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Holešov, 769 01
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Hranice I-Mesto, 753 01
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Krnov, 79401
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Pardubice, 53002
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Prague, 128 08

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Hungary5 sites

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Békéscsaba, 5600
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Budapest, 1212
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Gyula, 5700
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Veszprém, 8200
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Zalaegerszeg, 8900

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Italy5 sites

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Bergamo, 24128
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Bologna, 40138
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Olbia, 07026
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Pavia, 27100
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Rozzano, 20089

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Netherlands5 sites

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Dordrecht, 3317 NM
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Groningen, 9728 NT
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Heerlen, 6419 PC
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Hoogeveen, 7909AA
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Leiden, 2333 ZA

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Poland5 sites

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Krakow, 31-455
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Lublin, 20-538
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Sopot, 81-756
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Szczecin, 70-506
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Wroclaw, 50-306

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Puerto Rico5 sites

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Caguas, 00726
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Las Lomas, 00921
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Manati, 00674
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San Juan, 00917-3104
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Yabucoa, 00767

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Romania5 sites

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Brasov, 500283
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Cluj-Napoca, 400349
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Oradea, 410169
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Ploieşti, 100163
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Satu Mare, 440055

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Spain5 sites

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Barcelona, 08035
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Málaga, 29010
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Sabadell, 08208
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Seville, 41003
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Seville, 41010

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Turkey (Türkiye)5 sites

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Ankara, 06100
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Diyarbakır, 21280
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Istanbul, 34662
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Kayseri, 38039
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Kütahya, 43300

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Greece4 sites

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Ampelokipoi, 11527
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Athens, 11527
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Nikaias - Piraeus, 18454
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Thessaloniki, 54639

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Russia4 sites

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Arkhangelsk, 163045
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Moscow, 125367
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Rostov-on-Don, 344022
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Saint Petersburg, 198255

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Slovakia4 sites

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Dolný Kubín, 02601
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Košice, 04012
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Ľubochňa, 03491
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Rožňava, 048 01

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Taiwan4 sites

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Chiayi City, 600
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Sindian City, 23148
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Taichung, 404
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Yong Kung City, 71004

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United Kingdom4 sites

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Edinburgh, Scotland, EH4 2XU
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Guildford, Surrey, GU2 7XX
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Leicester, Leicestershire, LE5 4PW
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Middlesbrough, Cleveland, TS4 3BW

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Denmark3 sites

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Copenhagen, 2400
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Esbjerg, 6700
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Hillerød, 3400

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Japan3 sites

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Kanagawa, 235-0045
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Kumamoto, 862-0976
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Tokyo, 1030002

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Mexico3 sites

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Monterrey, 64460
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Querétaro, 76000
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Tampico, 89000

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Austria2 sites

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Graz, 8036
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Vienna, A1090

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Brazil2 sites

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Aparecida de Goiânia, 74935530
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Brasília, 71625-009

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Lithuania2 sites

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Kaunas, LT-48259
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Klaipėda, 92304

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About this study

Official 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

The purpose of this study is:

To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2605541, Insulin Glargine, Insulin Lispro
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2605541Drug
Also called Insulin Peglispro
Insulin GlargineDrug
Insulin LisproDrug
Also called Humalog

Study groups in NCT01468987
Study group	Role	What they receive
Insulin Glargine + Insulin Lispro	Active comparator	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. Receives: Drug: Insulin Glargine; Drug: Insulin Lispro
LY2605541 + Insulin Lispro	Experimental	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. Receives: Drug: LY2605541; Drug: Insulin Lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Measured: Baseline, 26 weeks

Secondary outcomes (19)

Total Hypoglycemia Rates (Adjusted for 30 Days)
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Measured: Baseline through 26 weeks
Percentage of Participants With Total Hypoglycemia Episodes
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Measured: Baseline through 26 weeks
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Measured: Baseline through 26 weeks
Percentage of Participants With Nocturnal Hypoglycemia Episodes
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Measured: Baseline through 26 weeks
Body Weight Change From Baseline to 26 Weeks
LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect.
Measured: Baseline, 26 weeks
Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values.
Measured: 26 weeks
Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Measured: up to 26 weeks
Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.
Measured: up to 26 weeks
Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]).
Measured: 26 weeks
Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG.
Measured: 26 weeks
Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability.
Measured: 26 weeks
0300-hour Blood Glucose to FBG Excursion at 26 Weeks
Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion.
Measured: 26 weeks
HbA1c at 26 Weeks
HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Measured: 26 weeks
Lipid Profile at 26 Weeks
Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.
Measured: 26 weeks
Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.
Measured: Baseline through 26 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate.
Measured: up to 26 weeks
Low Blood Sugar Survey (LBSS) at 26 Weeks
LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score.
Measured: 26 weeks
EuroQoL-5D (EQ-5D) at 26 Weeks
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score.
Measured: up to 26 weeks
Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100.
Measured: up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Aug 2013

First posted10 Nov 2011 (estimated)
Study startDec 2011
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,369 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01468987
Sponsor's protocol ID: 12145
Other IDs: I2R-MC-BIAM, 2011-001254-29
Acronym: IMAGINE 4
Status last verified: Mar 2018
First submitted: 8 Nov 2011
Last updated: 17 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
PubMed 36542287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01468987
Acronym / sponsor ID: IMAGINE 4 / 12145
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,369 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 10 Nov 2011 (estimated)
Results: Posted 17 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is:

To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Insulin Glargine + Insulin Lispro	Active comparator	Drug: Insulin Glargine, Drug: Insulin LisproParticipant-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.
LY2605541 + Insulin Lispro	Experimental	Drug: LY2605541, Drug: Insulin LisproParticipant-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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2605541Also: Insulin Peglispro	Drug	LY2605541 + Insulin Lispro
Insulin Glargine	Drug	Insulin Glargine + Insulin Lispro
Insulin LisproAlso: Humalog	Drug	Insulin Glargine + Insulin Lispro, LY2605541 + Insulin Lispro

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
Time frame: Baseline, 26 weeks
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.

19 secondary outcomes

Total Hypoglycemia Rates (Adjusted for 30 Days)
Time frame: Baseline through 26 weeks
Percentage of Participants With Total Hypoglycemia Episodes
Time frame: Baseline through 26 weeks
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
Time frame: Baseline through 26 weeks
Percentage of Participants With Nocturnal Hypoglycemia Episodes
Time frame: Baseline through 26 weeks
Body Weight Change From Baseline to 26 Weeks
Time frame: Baseline, 26 weeks
Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
Time frame: 26 weeks
Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
Time frame: up to 26 weeks
Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
Time frame: up to 26 weeks
Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
Time frame: 26 weeks
Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
Time frame: 26 weeks
Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
Time frame: 26 weeks
0300-hour Blood Glucose to FBG Excursion at 26 Weeks
Time frame: 26 weeks
HbA1c at 26 Weeks
Time frame: 26 weeks
Lipid Profile at 26 Weeks
Time frame: 26 weeks
Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
Time frame: Baseline through 26 weeks
Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
Time frame: up to 26 weeks
Low Blood Sugar Survey (LBSS) at 26 Weeks
Time frame: 26 weeks
EuroQoL-5D (EQ-5D) at 26 Weeks
Time frame: up to 26 weeks
Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
Time frame: up to 26 weeks

Results and safety

Results posted to the registry on 17 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2605541 + Insulin Lispro	691	620
Insulin Glargine + Insulin Lispro	678	618

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks

Time frame: Baseline, 26 weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	LY2605541 + Insulin Lispro n = 684	Insulin Glargine + Insulin Lispro n = 672
Value	-1.66 (0.04)	-1.45 (0.04)

Population analysed: Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2605541 + Insulin Lispro	79 of 691 (11.4%)	408 of 691 (59%)	Not reported
Insulin Glargine + Insulin Lispro	63 of 677 (9.3%)	406 of 677 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36542287Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

156 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LY2605541, Insulin Glargine and Insulin Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 156 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Germany, Australia, Croatia, Israel and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468987, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.