Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1369 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-12-31
Study Completion Date
2013-08-31
Brief Summary
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The purpose of this study is:
* To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
* To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
* To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.
* To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
* To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
* To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.
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Detailed Description
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Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Insulin Glargine + Insulin Lispro
Participant-specific dose of Insulin Glargine will be administered subcutaneously (SC) once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.
Group Type
ACTIVE_COMPARATOR
Insulin Glargine
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
LY2605541 + Insulin Lispro
Participant-specific dose of LY2605541 will be administered SC once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial and supplemental doses for 26 weeks.
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Interventions
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LY2605541
Intervention Type
DRUG
Insulin Glargine
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Other Intervention Names
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Insulin Peglispro
Humalog
Eligibility Criteria
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Inclusion Criteria
* Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
* Had diabetes ≥1 year
* Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
* Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
* Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
* This inclusion criterion applies ONLY to women of childbearing potential
* Are not breastfeeding
* Test negative for pregnancy at screening and randomization
* Do not intend to become pregnant during the study
* Have practiced a reliable method of birth control for at least 6 weeks prior to screening
* Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
* Have access to a method of communication with the site
* Have refrigeration in the home
* Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
* Have given written informed consent to participate in this study in accordance with local regulations
* Had diabetes ≥1 year
* Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
* Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
* Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
* This inclusion criterion applies ONLY to women of childbearing potential
* Are not breastfeeding
* Test negative for pregnancy at screening and randomization
* Do not intend to become pregnant during the study
* Have practiced a reliable method of birth control for at least 6 weeks prior to screening
* Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
* Have access to a method of communication with the site
* Have refrigeration in the home
* Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
* Have given written informed consent to participate in this study in accordance with local regulations
Exclusion Criteria
* Continuous subcutaneous insulin infusion therapy prior to screening
* Are using twice daily insulin glargine prior to screening
* Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
* Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
* Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
* Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
* Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\], acute or chronic hepatitis, non-alcoholic steatohepatitis \[NASH\], or elevated liver enzyme measurements as indicated below:
* total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
* alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>2.5X ULN as defined by the central laboratory, or
* aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \>2.5X ULN as defined by the central laboratory
* Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
* Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
* Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
* Have had an organ transplant
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol
* Are using twice daily insulin glargine prior to screening
* Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
* Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
* Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
* Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
* Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\], acute or chronic hepatitis, non-alcoholic steatohepatitis \[NASH\], or elevated liver enzyme measurements as indicated below:
* total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
* alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>2.5X ULN as defined by the central laboratory, or
* aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \>2.5X ULN as defined by the central laboratory
* Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
* Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
* Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
* Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
* Have had an organ transplant
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol
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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Mobile, Alabama, United States
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Camperdown, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Fremantle, Western Australia, Australia
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Graz, , Austria
Site Status
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Vienna, , Austria
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Aparecida de Goiânia, , Brazil
Site Status
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Brasília, , Brazil
Site Status
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Čakovec, , Croatia
Site Status
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Osijek, , Croatia
Site Status
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Rijeka, , Croatia
Site Status
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Slavonski Brod, , Croatia
Site Status
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Varaždin, , Croatia
Site Status
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Zagreb, , Croatia
Site Status
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Holešov, , Czechia
Site Status
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Hranice I-Mesto, , Czechia
Site Status
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Krnov, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Copenhagen, , Denmark
Site Status
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Esbjerg, , Denmark
Site Status
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Hillerød, , Denmark
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Berlin, , Germany
Site Status
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Burghausen, , Germany
Site Status
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Eisenach, , Germany
Site Status
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Essen, , Germany
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Falkensee, , Germany
Site Status
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Mainz, , Germany
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Mayen, , Germany
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Münster, , Germany
Site Status
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Neuwied, , Germany
Site Status
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Ampelokipoi, , Greece
Site Status
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Athens, , Greece
Site Status
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Nikaias - Piraeus, , Greece
Site Status
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Thessaloniki, , Greece
Site Status
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Békéscsaba, , Hungary
Site Status
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Budapest, , Hungary
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Gyula, , Hungary
Site Status
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Veszprém, , Hungary
Site Status
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Zalaegerszeg, , Hungary
Site Status
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Beersheba, , Israel
Site Status
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Holon, , Israel
Site Status
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Jerusalem, , Israel
Site Status
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Nahariya, , Israel
Site Status
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Safed, , Israel
Site Status
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Tel Litwinsky, , Israel
Site Status
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Bergamo, , Italy
Site Status
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Bologna, , Italy
Site Status
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Olbia, , Italy
Site Status
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Pavia, , Italy
Site Status
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Rozzano, , Italy
Site Status
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Kanagawa, , Japan
Site Status
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Kumamoto, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Kaunas, , Lithuania
Site Status
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Klaipėda, , Lithuania
Site Status
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Monterrey, , Mexico
Site Status
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Querétaro, , Mexico
Site Status
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Tampico, , Mexico
Site Status
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Dordrecht, , Netherlands
Site Status
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Groningen, , Netherlands
Site Status
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Heerlen, , Netherlands
Site Status
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Hoogeveen, , Netherlands
Site Status
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Leiden, , Netherlands
Site Status
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Krakow, , Poland
Site Status
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Lublin, , Poland
Site Status
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Sopot, , Poland
Site Status
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Szczecin, , Poland
Site Status
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Wroclaw, , Poland
Site Status
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Caguas, , Puerto Rico
Site Status
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Las Lomas, , Puerto Rico
Site Status
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Manatí, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Yabucoa, , Puerto Rico
Site Status
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Brasov, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Oradea, , Romania
Site Status
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Ploieşti, , Romania
Site Status
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Satu Mare, , Romania
Site Status
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Arkhangelsk, , Russia
Site Status
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Moscow, , Russia
Site Status
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Rostov-on-Don, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Dolný Kubín, , Slovakia
Site Status
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Košice, , Slovakia
Site Status
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Ľubochňa, , Slovakia
Site Status
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Rožňava, , Slovakia
Site Status
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Barcelona, , Spain
Site Status
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Málaga, , Spain
Site Status
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Sabadell, , Spain
Site Status
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Seville, , Spain
Site Status
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Seville, , Spain
Site Status
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Chiayi City, , Taiwan
Site Status
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Sindian City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Yong Kung City, , Taiwan
Site Status
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Ankara, , Turkey (Türkiye)
Site Status
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Diyarbakır, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Kayseri, , Turkey (Türkiye)
Site Status
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Kütahya, , Turkey (Türkiye)
Site Status
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Middlesbrough, Cleveland, United Kingdom
Site Status
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Leicester, Leicestershire, United Kingdom
Site Status
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Edinburgh, Scotland, United Kingdom
Site Status
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.
Guildford, Surrey, United Kingdom
Site Status
Countries
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United States
Australia
Austria
Brazil
Croatia
Czechia
Denmark
Germany
Greece
Hungary
Israel
Italy
Japan
Lithuania
Mexico
Netherlands
Poland
Puerto Rico
Romania
Russia
Slovakia
Spain
Taiwan
Turkey (Türkiye)
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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I2R-MC-BIAM
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001254-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12145
Identifier Type: -
Identifier Source: org_study_id
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