Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
455 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-01-31
Study Completion Date
2014-06-30
Brief Summary
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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.
* 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.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 1
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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LY2605541 + Insulin Lispro
LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Administered by SC injection with a pen device.
Insulin Lispro
Intervention Type
DRUG
Administered by SC injection with a pen device.
Glargine + Insulin Lispro
Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
Group Type
ACTIVE_COMPARATOR
Glargine
Intervention Type
DRUG
Administered by SC injection via a pen device.
Insulin Lispro
Intervention Type
DRUG
Administered by SC injection with a pen device.
Interventions
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Glargine
Administered by SC injection via a pen device.
Intervention Type
DRUG
LY2605541
Administered by SC injection with a pen device.
Intervention Type
DRUG
Insulin Lispro
Administered by SC injection with a pen device.
Intervention Type
DRUG
Other Intervention Names
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LY275585
Humalog
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Concord, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Huntington Beach, California, United States
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San Mateo, California, United States
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Aurora, Colorado, United States
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Idaho Falls, Idaho, United States
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Las Vegas, Nevada, United States
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Salt Lake City, Utah, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Graz, , Austria
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Vienna, , Austria
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Bar-le-Duc, , France
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Corbeil-Essonnes, , France
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Montpellier, , France
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Nantes, , France
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Nice, , France
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Saint-Mandé, , France
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Toulouse, , France
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Vénissieux, , France
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Berlin, , Germany
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Eisenach, , Germany
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Falkensee, , Germany
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Hamburg, , Germany
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Mainz, , Germany
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Mayen, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Pohlheim, , Germany
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Cagliari, , Italy
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Catania, , Italy
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Lecce, , Italy
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Padua, , Italy
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Perugia, , Italy
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Ravenna, , Italy
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Hokkaido, , Japan
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Kanagawa, , Japan
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Kumamoto, , Japan
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Tokyo, , Japan
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Guadalajara, , Mexico
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Guadalajara Jalisco, , Mexico
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Monterrey, , Mexico
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Katowice, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Arkhangelsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
Site Status
Countries
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United States
Austria
France
Germany
Italy
Japan
Mexico
Poland
Russia
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I2R-MC-BIAN
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001261-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12146
Identifier Type: -
Identifier Source: org_study_id
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