Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1114 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-01-31
Study Completion Date
2014-02-28
Brief Summary
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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
* 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
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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
DOUBLE
Participants
Investigators
Study Groups
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LY2605541 + Insulin Lispro
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.
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Glargine + Insulin Lispro
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.
Group Type
ACTIVE_COMPARATOR
Glargine
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Interventions
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Glargine
Intervention Type
DRUG
LY2605541
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Other Intervention Names
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LY275585
Humalog
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
Exclusion Criteria
* 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
* 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
* 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
* 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
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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Montreal, Quebec, Canada
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Osijek, , Croatia
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Copenhagen, , Denmark
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La Rochelle, , France
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Le Creuzot, , France
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Paris, , France
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Rouen, , France
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Athens, , Greece
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Chalcis, , Greece
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Thessaloniki, , Greece
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Dublin, , Ireland
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Jonava, , Lithuania
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Kaunas, , Lithuania
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Dordrecht, , Netherlands
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Groningen, , Netherlands
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Christchurch, , New Zealand
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Wellington, , New Zealand
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lubin, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Štúrovo, , Slovakia
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Houghton Estate, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Alcalá de Henares, , Spain
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Alzira, , Spain
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Barcelona, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Alingsås, , Sweden
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Helsingborg, , Sweden
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Huddinge, , Sweden
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Karlstad, , Sweden
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Bristol, Avon, United Kingdom
Site Status
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Portsmouth, Hampshire, United Kingdom
Site Status
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Blackburn, Lancashire, United Kingdom
Site Status
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Leicester, Leicestershire, United Kingdom
Site Status
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Inverness, Scotland, United Kingdom
Site Status
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Ipswich, Suffolk, United Kingdom
Site Status
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Guildford, Surrey, United Kingdom
Site Status
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Swansea, Wales, United Kingdom
Site Status
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Glasgow, , United Kingdom
Site Status
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Northampton, , United Kingdom
Site Status
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Oxford, , United Kingdom
Site Status
Countries
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United States
Australia
Belgium
Brazil
Canada
Croatia
Denmark
France
Greece
Ireland
Israel
Lithuania
Netherlands
New Zealand
Poland
Slovakia
South Africa
Spain
Sweden
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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
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I2R-MC-BIAO
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001253-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12147
Identifier Type: -
Identifier Source: org_study_id
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