A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
NCT ID: NCT01894568
Last Updated: 2019-03-15
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
388 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-07-31
Study Completion Date
2015-04-30
Brief Summary
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The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.
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Detailed Description
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Conditions
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Type 2 Diabetes Mellitus
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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Insulin Peglispro
Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).
Group Type
EXPERIMENTAL
Insulin Peglispro
Intervention Type
DRUG
Administered SC using a prefilled pen.
Oral Antihyperglycemic Medications (OAMs)
Intervention Type
DRUG
Administered orally
Insulin Glargine
Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.
Group Type
ACTIVE_COMPARATOR
Insulin Glargine
Intervention Type
DRUG
Administered SC using a prefilled pen
Oral Antihyperglycemic Medications (OAMs)
Intervention Type
DRUG
Administered orally
Interventions
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Insulin Peglispro
Administered SC using a prefilled pen.
Intervention Type
DRUG
Insulin Glargine
Administered SC using a prefilled pen
Intervention Type
DRUG
Oral Antihyperglycemic Medications (OAMs)
Administered orally
Intervention Type
DRUG
Other Intervention Names
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LY2605541
Sulfonylureas
Meglitinides
Dipeptidyl Peptidase-4 (DPP-IV) Inhibitors
Biguanides
α-Glucosidase Inhibitors
Pioglitazone
Eligibility Criteria
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Inclusion Criteria
* Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
* Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
* Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
* Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2)
* Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
* Record keeping as required by this protocol
* Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product
* Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
* Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
* Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2)
* Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
* Record keeping as required by this protocol
* Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product
Exclusion Criteria
* Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
* Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
* 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
* Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
* Are taking, or have taken within 3 months 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 had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
* 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 ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter \[μmol/L\]). Participants taking metformin should not exceed the creatinine level specified in the local label
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\]), acute or any 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
* Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
* Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
* 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 as determined by the central laboratory
* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
* Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
* 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
* Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
* Are taking, or have taken within 3 months 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 had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
* 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 ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter \[μmol/L\]). Participants taking metformin should not exceed the creatinine level specified in the local label
* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\]), acute or any 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
* Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
* Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
* 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 as determined by the central laboratory
* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
Minimum Eligible Age
20 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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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Aichi, , Japan
Site Status
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Chiba, , Japan
Site Status
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Fukuoka, , Japan
Site Status
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Hokkaido, , Japan
Site Status
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Hyōgo, , Japan
Site Status
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Ibaraki, , Japan
Site Status
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Kagawa, , Japan
Site Status
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Kanagawa, , Japan
Site Status
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Kumamoto, , Japan
Site Status
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Kyoto, , Japan
Site Status
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Miyagi, , Japan
Site Status
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Miyazaki, , Japan
Site Status
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Nagano, , Japan
Site Status
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Osaka, , Japan
Site Status
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Ōita, , Japan
Site Status
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Tochigi, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Yamaguchi, , Japan
Site Status
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Daegu, , South Korea
Site Status
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Incheon, , South Korea
Site Status
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Pusan, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Ulsan, , South Korea
Site Status
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Wŏnju, , South Korea
Site Status
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Sindian City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung County, , Taiwan
Site Status
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Tainan City, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Yongkang District, , Taiwan
Site Status
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Zhonghe, , Taiwan
Site Status
Countries
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Japan
South Korea
Taiwan
Other Identifiers
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I2R-JE-BIAQ
Identifier Type: OTHER
Identifier Source: secondary_id
13422
Identifier Type: -
Identifier Source: org_study_id
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