Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes
NCT ID: NCT01215955
Last Updated: 2014-04-23
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
1117 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-31
Study Completion Date
2013-01-31
Brief Summary
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Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.
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Detailed Description
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Participants who enter the study and are already taking insulin glargine with a screening HbA1c \>7.0% will be randomized to one of two treatment arms. Both arms will add prandial insulin to existing basal insulin therapy.
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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3 Day Algorithm
Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the past three days.
(Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B)
Group Type
EXPERIMENTAL
Insulin lispro
Intervention Type
DRUG
Administered subcutaneously, up to three times daily for 24 weeks
Glargine
Intervention Type
DRUG
Administered subcutaneously, dosage determined by investigator once daily for 24 weeks
Daily Algorithm
Basal insulin glargine plus mealtime bolus insulin lispro titrated based on blood glucose readings from the previous day.
(Sites were assigned to Study A and Study B according to an allocation plan that was pre-specified before initiation of Study A and Study B)
Group Type
EXPERIMENTAL
Insulin lispro
Intervention Type
DRUG
Administered subcutaneously, up to three times daily for 24 weeks
Glargine
Intervention Type
DRUG
Administered subcutaneously, dosage determined by investigator once daily for 24 weeks
Interventions
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Insulin lispro
Administered subcutaneously, up to three times daily for 24 weeks
Intervention Type
DRUG
Glargine
Administered subcutaneously, dosage determined by investigator once daily for 24 weeks
Intervention Type
DRUG
Other Intervention Names
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Humalog
LY275585
Eligibility Criteria
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Inclusion Criteria
* Have type 2 diabetes
* Have been treated for at least 90 days with insulin glargine, neutral protamine Hagedorn (NPH), or detemir in combination with oral antihyperglycemic agents as monotherapy, dual, or triple therapy \[sulfonylurea, meglitinide, metformin, pioglitazone, or dipeptidyl peptidase-4 (DPP-4) inhibitor\] and in the opinion of the investigator requires further intensification of therapy
* Are treated with insulin glargine, NPH, or detemir at least 20 units per day (U/day) at enrollment
* Have an glycated hemoglobin (HbA1c) value greater than 7.0% and less than or equal to 12.0% according to the central laboratory at screening
* Capable of and willing to do the following: inject insulin with a prefilled pen, perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator
* Have given written informed consent to participate in this study in accordance with local regulations
* Have been treated for at least 90 days with insulin glargine, neutral protamine Hagedorn (NPH), or detemir in combination with oral antihyperglycemic agents as monotherapy, dual, or triple therapy \[sulfonylurea, meglitinide, metformin, pioglitazone, or dipeptidyl peptidase-4 (DPP-4) inhibitor\] and in the opinion of the investigator requires further intensification of therapy
* Are treated with insulin glargine, NPH, or detemir at least 20 units per day (U/day) at enrollment
* Have an glycated hemoglobin (HbA1c) value greater than 7.0% and less than or equal to 12.0% according to the central laboratory at screening
* Capable of and willing to do the following: inject insulin with a prefilled pen, perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator
* Have given written informed consent to participate in this study in accordance with local regulations
Exclusion Criteria
* Prior rapid- or short-acting insulin therapy: participants receiving scheduled long-term short-acting or rapid-acting or premixed insulin therapy within the past 6 months will not be eligible to participate in the study. Participants who have previously received short- or rapid-acting insulin as part of short-term insulin therapy (during gestational diabetes, during an acute hospitalization or illness) or occasional use will be allowed to participate in this study. Occasional use (e.g., used to treat acute hyperglycemia) shall be defined as less than daily administration of not more than 1 dose per day of short- or rapid-acting insulin
* Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist, alpha-glucosidase inhibitor, or rosiglitazone use concurrently or within 3 months prior to entry into the study
* Severe hypoglycemia: have had more than one episode of severe hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
* Excessive insulin resistance: received a total daily dose of insulin greater than 2.0 units per kilogram (U/kg) at the time of randomization
* Morbid obesity: defined as a body mass index greater than or equal to 45 kilograms per square meter (kg/m²)
* Malignancy: have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
* Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (see New York Heart Association Cardiac Disease Classifications) or have Congestive Heart Failure (CHF) requiring pharmacologic treatment or, in the investigator's opinion, have severe dependent edema (i.e., edema of the feet or ankles) or have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis
* Renal: 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) if not on metformin
* Hepatic: have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) greater than 3 times the upper limit of the reference range as defined by the central laboratory
* Hematologic: have known hemoglobinopathy or chronic anemia or other known blood disorder
* Reproductive:(for women) are pregnant or intend to become pregnant during the course of the study; are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable; or are breastfeeding
* Allergy: have known allergy to insulin lispro, insulin glargine, or excipients contained in these products
* Glucocorticoid therapy: receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
* Adherence to protocol: have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the participant from following and completing the protocol
* Prior participation: are currently enrolled in, or have participated in, an interventional medical, surgical, or pharmaceutical drug or device or off-label use study (an investigational study in which a medical or surgical treatment was given) within 30 days prior to entry into the study, or persons who have previously completed or withdrawn from this study (after having signed the informed consent document). Participants may be ineligible if they are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Non-approved drug: have been treated with a drug within the last 30 days that has not received regulatory approval at the time of study entry
* Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist, alpha-glucosidase inhibitor, or rosiglitazone use concurrently or within 3 months prior to entry into the study
* Severe hypoglycemia: have had more than one episode of severe hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
* Excessive insulin resistance: received a total daily dose of insulin greater than 2.0 units per kilogram (U/kg) at the time of randomization
* Morbid obesity: defined as a body mass index greater than or equal to 45 kilograms per square meter (kg/m²)
* Malignancy: have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
* Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (see New York Heart Association Cardiac Disease Classifications) or have Congestive Heart Failure (CHF) requiring pharmacologic treatment or, in the investigator's opinion, have severe dependent edema (i.e., edema of the feet or ankles) or have any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis
* Renal: 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) if not on metformin
* Hepatic: have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) greater than 3 times the upper limit of the reference range as defined by the central laboratory
* Hematologic: have known hemoglobinopathy or chronic anemia or other known blood disorder
* Reproductive:(for women) are pregnant or intend to become pregnant during the course of the study; are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable; or are breastfeeding
* Allergy: have known allergy to insulin lispro, insulin glargine, or excipients contained in these products
* Glucocorticoid therapy: receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
* Adherence to protocol: have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the participant from following and completing the protocol
* Prior participation: are currently enrolled in, or have participated in, an interventional medical, surgical, or pharmaceutical drug or device or off-label use study (an investigational study in which a medical or surgical treatment was given) within 30 days prior to entry into the study, or persons who have previously completed or withdrawn from this study (after having signed the informed consent document). Participants may be ineligible if they are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Non-approved drug: have been treated with a drug within the last 30 days that has not received regulatory approval at the time of study entry
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 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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Phoenix, Arizona, United States
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Concord, California, United States
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Fresno, California, United States
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Jacksonville, Florida, United States
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Buenos Aires, , Argentina
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Rosario, , Argentina
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Vienna, , Austria
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Belém, , Brazil
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Curitiba, , Brazil
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Osijek, , Croatia
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Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Copenhagen, , Denmark
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Frederiksberg, , Denmark
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Kolding, , Denmark
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Bourges, , France
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La Bouëxière, , France
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Nantes, , France
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Kaunas, , Lithuania
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Cuauhtémoc, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
Site Status
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Lodz, , Poland
Site Status
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Lublin, , Poland
Site Status
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Poznan, , Poland
Site Status
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Szczecin, , Poland
Site Status
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Caguas, , Puerto Rico
Site Status
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Manatí, , Puerto Rico
Site Status
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Ponce, , Puerto Rico
Site Status
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Rio Piedras, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Bucharest, , Romania
Site Status
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Oradea, , Romania
Site Status
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Saint Petersburg, , Russia
Site Status
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Saratov, , Russia
Site Status
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Stavropol, , Russia
Site Status
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Halfway House, , South Africa
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.
Somerset West, , South Africa
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Argentina
Austria
Brazil
Canada
Croatia
Denmark
France
Lithuania
Mexico
Poland
Puerto Rico
Romania
Russia
South Africa
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F3Z-MC-IOQC
Identifier Type: OTHER
Identifier Source: secondary_id
13460
Identifier Type: -
Identifier Source: org_study_id
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