A Study of LY2605541 in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT01582451
Last Updated: 2018-04-20
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
466 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-31
Study Completion Date
2013-12-31
Brief Summary
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The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
* Change in participants' overall blood sugar control
* The rate of night time low blood sugar episodes
* The number of participants that reach blood sugar targets without low blood sugar episodes at night
* The rate of low blood sugar episodes reported over a 24-hour period
* Change in participants' overall blood sugar control
* The rate of night time low blood sugar episodes
* The number of participants that reach blood sugar targets without low blood sugar episodes at night
* The rate of low blood sugar episodes reported over a 24-hour period
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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
NONE
Study Groups
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LY2605541
Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Insulin glargine
Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Group Type
ACTIVE_COMPARATOR
Insulin glargine
Intervention Type
DRUG
Interventions
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LY2605541
Intervention Type
DRUG
Insulin glargine
Intervention Type
DRUG
Other Intervention Names
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Insulin peglispro
Eligibility Criteria
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Inclusion Criteria
* Have had type 2 diabetes mellitus for at least 1 year
* Have been receiving basal insulin (neutral protamine Hagedorn \[NPH\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
* Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
* Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2)
* Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
* Have been receiving basal insulin (neutral protamine Hagedorn \[NPH\], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
* Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
* Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m\^2)
* Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Exclusion Criteria
* Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
* Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
* For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
* Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
* Have had any episodes of severe hypoglycemia within 6 months prior to screening
* Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 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 or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter \[µmol/L\])
* 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
* 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 measurement of HbA1c
* Have active or untreated cancer, have been in remission from clinically significant cancer(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
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
* Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter \[mmol/L\]) at screening
* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
* Lipid-lowering medication: Are using or have used any of the following:
* niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
* lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
* Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
* For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
* Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss
* Have had any episodes of severe hypoglycemia within 6 months prior to screening
* Have had 1 or more episodes of diabetic ketoacidosis or hyperosmolar state/coma in the 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 or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter \[µmol/L\])
* 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
* 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 measurement of HbA1c
* Have active or untreated cancer, have been in remission from clinically significant cancer(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
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
* Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter \[mmol/L\]) at screening
* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
* Lipid-lowering medication: Are using or have used any of the following:
* niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
* lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
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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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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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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Spring Valley, California, United States
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Fort Lauderdale, Florida, United States
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New Port Richey, Florida, United States
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Oviedo, Florida, United States
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Roswell, Georgia, United States
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Crystal Lake, Illinois, United States
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Toms River, New Jersey, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Round Rock, Texas, United States
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Bountiful, Utah, United States
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Federal Way, Washington, United States
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Olympia, Washington, United States
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Milwaukee, Wisconsin, United States
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Beroun, , Czechia
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Brandýs nad Labem, , Czechia
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Prague, , Czechia
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Aschaffenburg, , Germany
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Bad Mergentheim, , Germany
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Damme, , Germany
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Dresden, , Germany
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Rhaunen, , Germany
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Chalcis, , Greece
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Thessaloniki, , Greece
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Acre, , Israel
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Beersheba, , Israel
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Holon, , Israel
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Nazareth, , Israel
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Raanana, , Israel
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Bayamón, , Puerto Rico
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Ponce, , Puerto Rico
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Bucharest, , Romania
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Oradea, , Romania
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Sibiu, , Romania
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Arkhangelsk, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Alzira, , Spain
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Cadiz, , Spain
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Palma de Mallorca, , Spain
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Pozuelo de Alarcón, , Spain
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Teruel, , Spain
Site Status
Countries
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United States
Czechia
Germany
Greece
Israel
Puerto Rico
Romania
Russia
Spain
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
Buse JB, Rodbard HW, Trescoli Serrano C, Luo J, Ivanyi T, Bue-Valleskey J, Hartman ML, Carey MA, Chang AM; IMAGINE 5 Investigators. Randomized Clinical Trial Comparing Basal Insulin Peglispro and Insulin Glargine in Patients With Type 2 Diabetes Previously Treated With Basal Insulin: IMAGINE 5. Diabetes Care. 2016 Jan;39(1):92-100. doi: 10.2337/dc15-1531. Epub 2015 Nov 17.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I2R-MC-BIDJ
Identifier Type: OTHER
Identifier Source: secondary_id
14703
Identifier Type: -
Identifier Source: org_study_id
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