Clinical trial NCT01481779: A Study in Participants With Type 1 Diabetes Mellitus
Official title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
* To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 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 78 weeks of treatment.
* To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Have had diabetes mellitus for at least 1 year
* Have an hemoglobin A1c (HbA1c) value less than 12% according to the central laboratory at screening
* Have a body mass index (BMI) 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 the following:

  * Insulin detemir, insulin glargine, or human insulin isophane suspension (NPH) insulin in combination with premeal insulin,
  * Self-mixed or premixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
  * Continuous SC insulin infusion therapy
* This inclusion criterion applies to female participants:

  * Are not breastfeeding
  * Test negative for pregnancy at screening and randomization based on serum pregnancy tests
  * Do not intend to become pregnant during the study
  * Have practiced a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, intrauterine devices, partner with vasectomy, or abstinence) 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)
* Capable of and willing and desirous to do the following: adhere to a multiple daily injection regimen, inject insulin with a prefilled pen and perform Self-Monitored Blood Glucose (SMBG) and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above.

Exclusion Criteria:

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

  * 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 greater than or equal to 90 days prior to screening
  * If a participant has not been on a stable dose of lipid-lowering medication for greater than or equal to 90 days prior to screening, the site should wait to screen the participant. If the results of the screening laboratory tests require a change to the participant's current lipid-lowering medication or initiation of lipid-lowering medication, it is acceptable to change the lipid-lowering medication for the participant and to have the participant return greater than or equal to 90 days later to complete some of the screening procedures again
* 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 as determined by the investigator) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control (hyperglycemia or diabetic ketoacidosis) in the past 6 months
* Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Renal: Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than 2.5 mg/dL
* Hepatic: 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 greater than or equal to 2 times the upper limit of normal (ULN) as defined by the central laboratory,
  * Alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) greater than 2.5 times ULN as defined by the central laboratory, or
  * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN as defined by the central laboratory.
* Malignancy: 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 an increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Allergy: Have known hypersensitivity or allergy to any of the study insulins or their excipients
* Hematologic: Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
* Glucocorticoid therapy: 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 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) at 26 Weeks
timeFrame: 26 weeks
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: 52 weeks and 78 weeks
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 26 weeks, 52 weeks, 78 weeks
measure: Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Total Hypoglycemia Rates (Adjusted by 30 Days)
timeFrame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
measure: Percentage of Participants With Total Hypoglycemia Events
timeFrame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
measure: Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)
timeFrame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
measure: Percentage of Participants With Nocturnal Hypoglycemic Events
timeFrame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
measure: Fasting Serum Glucose (FSG) by Laboratory Measurement
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Fasting Blood Glucose (FBG) Intra-participant Variability
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: 0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: 9 Point Self-monitored Blood Glucose (SMBG)
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline and 26 weeks and 52 weeks and 78 weeks
measure: Basal, Bolus, and Total Insulin Dose
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Lipid Profile
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: Percentage of Participants With Change in Anti-LY2605541 Antibodies
timeFrame: Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ)
timeFrame: 26 weeks
measure: Low Blood Sugar Survey (LBSS)
timeFrame: 26 weeks and 52 weeks and 78 weeks
measure: European Quality of Life-5 Dimension (EQ-5D)
timeFrame: 26 weeks
measure: Rapid Assessment of Physical Activity (RAPA)
timeFrame: 26 weeks and 78 weeks
Other outcomes:
Locations:
city: Concord
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Escondido
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Fresno
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Greenbrae
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Huntington Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: San Mateo
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Aurora
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Colorado
city: Idaho Falls
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Idaho
city: Las Vegas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nevada
city: Salt Lake City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Utah
city: Renton
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Graz
country: Austria
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city: Vienna
country: Austria
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city: Bar Le Duc
country: France
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city: Corbeil-Essonnes
country: France
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city: Montpellier
country: France
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city: Nantes
country: France
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city: Nice
country: France
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city: Saint Mande
country: France
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city: Toulouse
country: France
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city: Venissieux
country: France
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city: Berlin
country: Germany
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city: Eisenach
country: Germany
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city: Falkensee
country: Germany
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city: Hamburg
country: Germany
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city: Mainz
country: Germany
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city: Mayen
country: Germany
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city: Münster
country: Germany
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city: Neuwied
country: Germany
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city: Pohlheim
country: Germany
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city: Cagliari
country: Italy
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city: Catania
country: Italy
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city: Lecce
country: Italy
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city: Padova
country: Italy
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city: Perugia
country: Italy
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city: Ravenna
country: Italy
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city: Hokkaido
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kanagawa
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kumamoto
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Guadalajara Jalisco
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Guadalajara
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Monterrey
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Katowice
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lodz
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Poznan
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Warsaw
country: Poland
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city: Arkhangelsk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.