A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
NCT ID: NCT01790438
Last Updated: 2018-05-03
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
641 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-03-31
Study Completion Date
2014-05-31
Brief Summary
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The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 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 night time blood sugar episodes
* The total number of low blood sugar episodes reported
* 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 night time blood sugar episodes
* The total number of low blood sugar episodes reported
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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 (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications \[OAM(s)\] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
Group Type
EXPERIMENTAL
LY2605541
Intervention Type
DRUG
Oral Antihyperglycemic Medications (OAM)
Intervention Type
DRUG
Human Insulin NPH
Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
Group Type
ACTIVE_COMPARATOR
Human Insulin NPH
Intervention Type
DRUG
Oral Antihyperglycemic Medications (OAM)
Intervention Type
DRUG
Interventions
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LY2605541
Intervention Type
DRUG
Human Insulin NPH
Intervention Type
DRUG
Oral Antihyperglycemic Medications (OAM)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
* Have been receiving 2 or more OAMs for at least 3 months prior to the study
* Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, 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 2 or more OAMs for at least 3 months prior to the study
* Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, 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 used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
* Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or over-the-counter medications to promote weight loss
* Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma 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 or equal to 2 milligrams per deciliter (mg/dL) \[177 millimoles per liter (mmol/L)\]
* Have obvious clinical signs or symptoms of liver disease \[excluding nonalcoholic fatty liver disease (NAFLD)\], acute or chronic hepatitis, nonalcoholic 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 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
* Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
* Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or over-the-counter medications to promote weight loss
* Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma 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 or equal to 2 milligrams per deciliter (mg/dL) \[177 millimoles per liter (mmol/L)\]
* Have obvious clinical signs or symptoms of liver disease \[excluding nonalcoholic fatty liver disease (NAFLD)\], acute or chronic hepatitis, nonalcoholic 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 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
* Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or 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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Tempe, Arizona, United States
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Concord, California, United States
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Fresno, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Jacksonville, Florida, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Bloomfield Hills, Michigan, United States
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Nashua, New Hampshire, United States
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Greensboro, North Carolina, United States
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Eugene, Oregon, United States
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Levittown, Pennsylvania, United States
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Greer, South Carolina, United States
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Knoxville, Tennessee, United States
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Spokane, Washington, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Mar del Plata, , Argentina
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Spruce Grove, Alberta, Canada
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Burnaby, British Columbia, Canada
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Kelowna, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Sherbrooke, Quebec, Canada
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Brandýs nad Labem, , Czechia
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Pardubice, , Czechia
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Plzen 2-Slovany, , Czechia
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Prague, , Czechia
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Eisenach, , Germany
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Hohenmölsen, , Germany
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Münster, , Germany
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Saarbrücken, , Germany
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Saint Ingbert-Oberwürzbach, , Germany
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Schkeuditz, , Germany
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Nagykanizsa, , Hungary
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Pápa, , Hungary
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Gdynia, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Las Lomas, , Puerto Rico
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Yabucoa, , Puerto Rico
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Bucheon-si, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Seoul, , South Korea
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Sungnam-Si, , South Korea
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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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Teruel, , Spain
Site Status
Countries
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United States
Argentina
Canada
Czechia
Germany
Hungary
Mexico
Poland
Puerto Rico
South Korea
Spain
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
Other Identifiers
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I2R-MC-BIAK
Identifier Type: OTHER
Identifier Source: secondary_id
2012-003941-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12143
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
A Study in Participants With Type I Diabetes Mellitus
NCT01454284
COMPLETED
PHASE3
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
NCT01191268
COMPLETED
PHASE3
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
NCT03341312
COMPLETED
PHASE1
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
NCT01075282
COMPLETED
PHASE3
A Study in Participants With Type 2 Diabetes Mellitus
NCT01468987
COMPLETED
PHASE3
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
NCT00664534
COMPLETED
PHASE4
A Study in Participants With Type 1 Diabetes Mellitus
NCT01481779
COMPLETED
PHASE3
A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
NCT01894568
COMPLETED
PHASE3
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
NCT03952143
COMPLETED
PHASE3
A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
NCT01871493
COMPLETED
PHASE1
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
NCT00653341
COMPLETED
PHASE3
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
NCT02955953
COMPLETED
PHASE1
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
NCT05048719
COMPLETED
PHASE2
A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
NCT04957914
COMPLETED
PHASE1
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
NCT05362058
COMPLETED
PHASE3
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
NCT03286751
COMPLETED
PHASE1
A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects
NCT01374178
COMPLETED
PHASE1
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
NCT00494013
COMPLETED
PHASE3
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
NCT03830281
COMPLETED
PHASE3
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
NCT00560417
COMPLETED
PHASE3
Simplification of Complex Insulin Regimens With Preserving Good Glycemic Control in Type 2 Diabetes
NCT04020445
COMPLETED
A Study of A Novel Approach to Titrate Basal Insulin (LY2963016) in Participants With Type 2 Diabetes
NCT04864977
WITHDRAWN
PHASE4
Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2)
NCT00659477
COMPLETED
PHASE4
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
NCT01484262
COMPLETED