Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1538 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-11-30
Study Completion Date
2014-01-31
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 night time 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 after 52 weeks of treatment
* To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
* To compare the rate of night time 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 after 52 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
DOUBLE
Participants
Investigators
Study Groups
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LY2605541
LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Glargine
Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Group Type
ACTIVE_COMPARATOR
Glargine
Intervention Type
DRUG
Interventions
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Glargine
Intervention Type
DRUG
LY2605541
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
* Have been receiving at least 2 OAMs for at least 3 months before entering the study
* Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
* Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
* Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
* Have been receiving at least 2 OAMs for at least 3 months before entering the study
* Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
* Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
* Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Exclusion Criteria
* Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
* Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
* Are currently taking, or have taken within the 3 months preceding screening, 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 ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association \[NYHA\] Cardiac Disease Classification)
* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (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 at screening
* 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 malignancy or have been in remission from clinically significant malignancy for less than 5 years
* Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter \[mmol/L\]) at screening
* Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
* Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
* Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
* Are currently taking, or have taken within the 3 months preceding screening, 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 ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association \[NYHA\] Cardiac Disease Classification)
* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (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 at screening
* 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 malignancy or have been in remission from clinically significant malignancy for less than 5 years
* Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter \[mmol/L\]) at screening
* Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
* Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 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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Buenos Aires, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Merewether, New South Wales, Australia
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Fremantle, Western Australia, Australia
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Marília, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Setor Oeste/Goiania, , Brazil
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Etobicoke, Ontario, Canada
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Markham, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Oulu, , Finland
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Seinäjoki, , Finland
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Dippoldiswalde, , Germany
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Dresden, , Germany
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Friedrichsthal, , Germany
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Furth im Wald, , Germany
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Goch, , Germany
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Hamburg, , Germany
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Ludwigshafen, , Germany
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Münster, , Germany
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Saarbrücken, , Germany
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Schweinfurt, , Germany
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Sulzbach, , Germany
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Ampelokipoi, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Makó, , Hungary
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Salgótarján, , Hungary
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Sopron, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Raanana, , Israel
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Carpi, , Italy
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Castellanza, , Italy
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Foggia, , Italy
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Forlì, , Italy
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Rome, , Italy
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Sesto San Giovanni, , Italy
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Utena, , Lithuania
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Vilnius, , Lithuania
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Coatzacoalcos, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Auckland, , New Zealand
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Kamieniec Ząbkowicki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Ruda Śląska, , Poland
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Szczecin, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Hato Rey, , Puerto Rico
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Oradea, , Romania
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Ploieşti, , Romania
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Reşiţa, , Romania
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Târgu Mureş, , Romania
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Cheboksary, , Russia
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Kazan', , Russia
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Kursk, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Bratislava, , Slovakia
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Šaľa, , Slovakia
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Vranov nad Topľou, , Slovakia
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Paarl, , South Africa
Site Status
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Parow, , South Africa
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Somerset West, , South Africa
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Alicante, , Spain
Site Status
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Córdoba, , Spain
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Pozuelo de Alarcón, , Spain
Site Status
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Requena, , Spain
Site Status
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Seville, , Spain
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Toledo, , Spain
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Gaziantep, , Turkey (Türkiye)
Site Status
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Hatay, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Site Status
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Kayseri, , Turkey (Türkiye)
Site Status
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Mortimer, Berks, United Kingdom
Site Status
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Leicester, Leicestershire, United Kingdom
Site Status
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Guildford, Surrey, United Kingdom
Site Status
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Swansea, Wales, United Kingdom
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Argentina
Australia
Brazil
Canada
Finland
Germany
Greece
Hungary
Israel
Italy
Lithuania
Mexico
New Zealand
Poland
Puerto Rico
Romania
Russia
Slovakia
South Africa
Spain
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
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-BIAJ
Identifier Type: OTHER
Identifier Source: secondary_id
12141
Identifier Type: -
Identifier Source: org_study_id
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