Diabetes Mellitus, Type 1Phase 3IMAGINE 3NCT01454284

A Study in Participants With Type I Diabetes Mellitus

A Phase 3 study testing Glargine, LY2605541 and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 119 sites in 20 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 sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 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 1
What is being tested?: Glargine, LY2605541 and Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,114 participants
Where: 119 sitesin 20 countries
Study dates: Jan 2012to Feb 2014
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

Type 1 diabetes for at least 1 year
HbA1c value less than 12 percent according to the central laboratory at screening
Body mass index of less than or equal to 35.0 kilograms per square meter (kg/m^2)
Have been treated for at least 90 days prior to screening with
insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH) in combination with pre-meal insulin, or
self-mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or

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continuous SC insulin infusion therapy
Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 2 weeks after last treatment with study drug
Are capable and willing to adhere to multiple daily injections, inject with a vial and syringe and prefilled pen and perform self-monitored blood glucose (SMBG) readings and record keeping

Who cannot join

Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening
Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (U/kg) at the time of randomization
Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening
Lipid lowering medications:
are using niacin preparations as 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 or more prior to screening

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Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as determined by the central laboratory.
Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening
Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within 6 months prior to screening
Have cardiac disease with functional status that is New York Heart Association Class III or IV
Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
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 2 times or more than the upper limit of normal (ULN) as defined by the central laboratory, or
alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more than 2.5 times ULN as defined by the central laboratory, or
aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) more than 2.5 times 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
Diagnosed clinically significant diabetic autonomic neuropathy

Trial locations and contacts

119 sites in 20 countries.

Country

City, postcode or hospital

119 sites in 20 countries

United States47 sites

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Albany, New York, 12208
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Aurora, Colorado, 80045
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Austin, Texas, 78731
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Baltimore, Maryland, 21204
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Billings, Montana, 59101
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Bradenton, Florida, 34208
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Chattanooga, Tennessee, 37411
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Chesterfield, Missouri, 63017
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Concord, California, 94520
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Dallas, Texas, 75231
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Des Moines, Iowa, 50314
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Durham, North Carolina, 27713
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Eagan, Minnesota, 55123
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Eugene, Oregon, 97401
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Federal Way, Washington, 98003
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Fresno, California, 93720
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Greer, South Carolina, 29651
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96814
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Houston, Texas, 77095
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32258
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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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Longmont, Colorado, 80501
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Mentor, Ohio, 44060
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Metairie, Louisiana, 70006
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Minneapolis, Minnesota, 55416
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Morehead City, North Carolina, 28557
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Myrtle Beach, South Carolina, 29572
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Nashua, New Hampshire, 03063
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New Port Richey, Florida, 34652
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Ogden, Utah, 84403
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Omaha, Nebraska, 68114
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Portland, Oregon, 97210
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Roswell, Georgia, 30076
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Round Rock, Texas, 78681
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Spokane, Washington, 99202
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Springfield, Illinois, 62704
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Springfield, Missouri, 65807
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Tacoma, Washington, 98405
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Topeka, Kansas, 66606
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Tustin, California, 92780
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West Palm Beach, Florida, 33401
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Wichita, Kansas, 67226

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United Kingdom11 sites

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Blackburn, Lancashire, BB2 3HH
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Bristol, Avon, BS10 5NB
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Glasgow, G21 3UW
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Guildford, Surrey, GU2 7XX
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Inverness, Scotland, IV2 3JH
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Ipswich, Suffolk, IP4 5PD
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Leicester, Leicestershire, LE5 4PW
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Northampton, NN1 5BD
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Oxford, OX3 7LJ
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Portsmouth, Hampshire, P06 3LY
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Swansea, Wales, SA6 6NL

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Canada7 sites

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Edmonton, Alberta, T5J 3N4
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Halifax, Nova Scotia, B3H 2Y9
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Laval, Quebec, H7T 2P5
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Montreal, Quebec, H2W 1T8
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Oakville, Ontario, L6H 3P1
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Red Deer, Alberta, T4N 6V7
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Winnipeg, Manitoba, R3E 3P4

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Poland7 sites

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Gdansk, 80-546
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Katowice, 40-057
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Krakow, 31-261
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Lubin, 59-300
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Lublin, 20-538
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Szczecin, 70-506
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Warsaw, 02-507

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Spain7 sites

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Alcalá de Henares, 28805
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Alzira, 46600
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Barcelona, 08036
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Málaga, 29006
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Seville, 41003
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Seville, 41014
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Valencia, 46014

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Israel5 sites

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Haifa, 31096
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Jerusalem, 91120
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Petah Tikva, 49100
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Petah Tikva, 49451
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Tel HaShomer, 52621

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Australia4 sites

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Box Hill, Victoria, 3128
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Keswick, South Australia, 5035
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Merewether, New South Wales, 2291
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Parkville, Victoria, 3050

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Belgium4 sites

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Brussels, 1070
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Edegem, 2650
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Huy, 4500
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Sint-Niklaas, 9100

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France4 sites

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La Rochelle, 17019
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Le Creuzot, 71200
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Paris, 75022
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Rouen, 76031

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Sweden4 sites

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Alingsås, 44183
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Helsingborg, 25187
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Huddinge, 14186
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Karlstad, SE-651 85

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Brazil3 sites

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Fortaleza, 60430-350
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Porto Alegre, 91350250
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São Paulo, 01244-030

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Greece3 sites

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Athens, 10552
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Chalcis, 341 00
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Thessaloniki, 56429

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South Africa3 sites

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Houghton Estate, 2198
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Pretoria, 0002
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Somerset West, 7130

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Lithuania2 sites

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Jonava, LT-55201
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Kaunas, LT-51270

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Netherlands2 sites

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Dordrecht, 3317 NM
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Groningen, 9728 NT

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New Zealand2 sites

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Christchurch, 8001
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Wellington, 6021

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Croatia1 site

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Osijek, 31000

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Denmark1 site

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Copenhagen, 2400

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Ireland1 site

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Dublin

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Slovakia1 site

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Štúrovo, 943 01

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About this study

Official title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

The purpose of this study is:

To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

Conditions: Diabetes Mellitus, Type 1
Being tested: Glargine, LY2605541, Insulin Lispro
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

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

GlargineDrug
LY2605541Drug
Insulin LisproDrug
Also called LY275585, Humalog

Study groups in NCT01454284
Study group	Role	What they receive
LY2605541 + Insulin Lispro	Experimental	LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks. Receives: Drug: LY2605541; Drug: Insulin Lispro
Glargine + Insulin Lispro	Active comparator	Glargine dose titrated based on blood glucose readings, administered SC once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered SC at meal times for 52 weeks. Receives: Drug: Glargine; Drug: Insulin Lispro

What is being measured

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

Hemoglobin A1c (HbA1c)
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 treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Measured: 52 weeks

Secondary outcomes (21)

Hemoglobin A1c (HbA1c)
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 treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Measured: 26 weeks
Change From Baseline to 52 Weeks in HbA1c
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Measured: Baseline, 52 weeks
Total Hypoglycemia Events
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 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, Baseline through 52 weeks
Percentage of Participants With Total Hypoglycemic Events
Hypoglycemic episodes are defined as events that are associated with the 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, Baseline through 52 weeks
Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%
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, up to 52 weeks
Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia
Hypoglycemic episodes are defined as events 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, up to 52 weeks
Nocturnal Hypoglycemia Rates
Hypoglycemic episodes are defined as events that 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, Baseline through 52 weeks
Percentage of Participants With Nocturnal Hypoglycemic Events
Hypoglycemic episodes are defined as events associated with the 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, Baseline through 52 weeks
Change in Body Weight
LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect.
Measured: Baseline, 26 weeks, 52 weeks
9 Point Self-monitored Blood Glucose (SMBG)
9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, and 52. 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 treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline BG values as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
Fasting Serum Glucose (by Laboratory Measurement)
Fasting serum glucose (FSG) is measured in blood before the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)
Fasting blood glucose (FBG) was measured by SMBG pre-morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline FBG as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
Intra-participant Variability of Fasting Blood Glucose (FBG)
FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation (SD) of FBG. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline SD of FBG as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
0300 Hours Blood Glucose (BG) to Fasting BG Excursion
Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only excursions within a single SMBG profile are included). LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline excursion as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol
Concentrations of cholesterol, HDL-C, and LDL-C, and triglycerides are presented. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L), except for the LDL-C outcome variable], prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable as the fixed effects and participant as a random effect.
Measured: 26 weeks and 52 weeks
Percentage of Participants With Change in Anti-LY2605541 Antibodies
The percentage of participants with anti-LY2605541 treatment-emergent 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: 26 weeks, 52 weeks
Basal, Meal Time, and Total Insulin Dose Per Body Weight
Basal insulin dose, meal-time insulin dose (short-acting bolus dose), 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 postbaseline visit and stratification variables (baseline HbA1c [≤8.5% and> 8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], and baseline prior basal insulin therapy [insulin glargine/detemir/ other]) as fixed effects.
Measured: 26 weeks and 52 weeks
Insulin Treatment Satisfaction Questionnaire
Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated measure containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Convenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data are transformed to a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an ANCOVA model adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, and baseline prior basal insulin therapy (insulin glargine/detemir/other) as fixed effects and baseline ITSQ scores as a covariate.
Measured: up to 52 weeks
European Quality of Life -5 Dimension (EQ-5D-3L)
The EQ-5D-3L 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 an ANCOVA adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), and baseline EQ-5D-3L score as covariates.
Measured: up to 52 weeks
Adult Low Blood Sugar Survey
Low Blood Sugar Survey (LBSS) (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 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-type 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 adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), visit, treatment-by-visit interaction, and baseline LBSS score as the fixed effects and participant as the random effect.
Measured: 26 weeks and 52 weeks
Rapid Assessment of Physical Activity (RAPA)
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 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: 52 weeks

Timeline

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

Jan 2012Feb 2014

First posted18 Oct 2011 (estimated)
Study startJan 2012
Primary completionFeb 2014
Study completionFeb 2014

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 (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01454284
Sponsor's protocol ID: 12147
Other IDs: I2R-MC-BIAO, 2011-001253-82
Acronym: IMAGINE 3
Status last verified: Mar 2018
First submitted: 14 Oct 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
Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
PubMed 29167192
Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
PubMed 28587667
Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.
PubMed 28417532

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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 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study
ClinicalTrials.gov ID: NCT01454284
Acronym / sponsor ID: IMAGINE 3 / 12147
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,114 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 18 Oct 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 sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY2605541 + Insulin Lispro	Experimental	Drug: LY2605541, Drug: Insulin LisproLY2605541 titrated based on blood glucose readings, administered subcutaneously (SC) once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered SC at meal times for 52 weeks.
Glargine + Insulin Lispro	Active comparator	Drug: Glargine, Drug: Insulin LisproGlargine dose titrated based on blood glucose readings, administered SC once daily at bedtime for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered SC at meal times for 52 weeks.

Who may qualify

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

Key inclusion criteria (9 listed)

Type 1 diabetes for at least 1 year
HbA1c value less than 12 percent according to the central laboratory at screening
Body mass index of less than or equal to 35.0 kilograms per square meter (kg/m^2)
Have been treated for at least 90 days prior to screening with
Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 2 weeks after last treatment with study drug

Key exclusion criteria (17 listed)

Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening
Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 units per kilogram (U/kg) at the time of randomization
Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening
Lipid lowering medications:
Have fasting hypertriglyceridemia (defined as greater than 4.5 millimoles per liter [mmol/L], greater than 400 milligrams per deciliter [mg/dL]) at screening, as determined by the central laboratory.

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
Glargine	Drug	Glargine + Insulin Lispro
LY2605541	Drug	LY2605541 + Insulin Lispro
Insulin LisproAlso: LY275585, Humalog	Drug	Glargine + Insulin Lispro, LY2605541 + Insulin Lispro

Primary outcome

Hemoglobin A1c (HbA1c)
Time frame: 52 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 treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.

21 secondary outcomes

Hemoglobin A1c (HbA1c)
Time frame: 26 weeks
Change From Baseline to 52 Weeks in HbA1c
Time frame: Baseline, 52 weeks
Total Hypoglycemia Events
Time frame: Baseline through 26 weeks, Baseline through 52 weeks
Percentage of Participants With Total Hypoglycemic Events
Time frame: Baseline through 26 weeks, Baseline through 52 weeks
Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%
Time frame: up to 26 weeks, up to 52 weeks
Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia
Time frame: up to 26 weeks, up to 52 weeks
Nocturnal Hypoglycemia Rates
Time frame: Baseline through 26 weeks, Baseline through 52 weeks
Percentage of Participants With Nocturnal Hypoglycemic Events
Time frame: Baseline through 26 weeks, Baseline through 52 weeks
Change in Body Weight
Time frame: Baseline, 26 weeks, 52 weeks
9 Point Self-monitored Blood Glucose (SMBG)
Time frame: 26 weeks and 52 weeks
Fasting Serum Glucose (by Laboratory Measurement)
Time frame: 26 weeks and 52 weeks
Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)
Time frame: 26 weeks and 52 weeks
Intra-participant Variability of Fasting Blood Glucose (FBG)
Time frame: 26 weeks and 52 weeks
0300 Hours Blood Glucose (BG) to Fasting BG Excursion
Time frame: 26 weeks and 52 weeks
Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol
Time frame: 26 weeks and 52 weeks
Percentage of Participants With Change in Anti-LY2605541 Antibodies
Time frame: 26 weeks, 52 weeks
Basal, Meal Time, and Total Insulin Dose Per Body Weight
Time frame: 26 weeks and 52 weeks
Insulin Treatment Satisfaction Questionnaire
Time frame: up to 52 weeks
European Quality of Life -5 Dimension (EQ-5D-3L)
Time frame: up to 52 weeks
Adult Low Blood Sugar Survey
Time frame: 26 weeks and 52 weeks
Rapid Assessment of Physical Activity (RAPA)
Time frame: 52 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	664	548
Insulin Glargine + Insulin Lispro	450	377

Primary outcome: Hemoglobin A1c (HbA1c)

Time frame: 52 weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	LY2605541 + Insulin Lispro n = 648	Insulin Glargine + Insulin Lispro n = 444
Value	7.38 (0.03)	7.61 (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.

21 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2605541 + Insulin Lispro	117 of 663 (17.6%)	502 of 663 (75.7%)	Not reported
Insulin Glargine + Insulin Lispro	92 of 449 (20.5%)	305 of 449 (67.9%)	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.
Derived from this study: PubMed 29167192Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.
Derived from this study: PubMed 28587667Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.
Derived from this study: PubMed 28417532Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

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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

119 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glargine, LY2605541 and Insulin Lispro in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 119 sites in 20 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 9 inclusion and 17 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 119 sites in United States, United Kingdom, Canada, Poland, Spain and 15 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?

Hemoglobin A1c (HbA1c) (time frame: 52 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 NCT01454284, which also lists 4 linked publications.

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.