Clinical trial NCT01790438: A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
Official title: A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

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

Primary outcomes:
measure: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 26 Weeks
Secondary outcomes:
measure: 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
timeFrame: Baseline through 26 Weeks
measure: Percentage of Participants With HbA1c ≤6.5% and <7.0%
timeFrame: 26 Weeks
measure: Fasting Serum Glucose (FSG) (by Laboratory)
timeFrame: 26 Weeks
measure: Fasting Blood Glucose (FBG) (by Self Monitoring)
timeFrame: 26 Weeks
measure: 6-Point Self-Monitored Blood Glucose (SMBG)
timeFrame: 26 Weeks
measure: Change From Baseline to 26 Weeks in Body Weight
timeFrame: Baseline, 26 Weeks
measure: HbA1c
timeFrame: 26 Weeks
measure: Insulin Dose Per Kilogram (kg) of Body Weight
timeFrame: 26 Weeks
measure: Time to Steady-State (Stable Maximum Dose)
timeFrame: Baseline through 26 Weeks
measure: Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
timeFrame: Baseline, 26 Weeks
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
timeFrame: 26 Weeks
measure: Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline to 26 Weeks in Lipid Profile
timeFrame: Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)
measure: Percentage of Participants With Insulin Antibodies
timeFrame: Baseline to 26 Weeks
measure: Intra-Participant Variability in FBG by Standard Deviation
timeFrame: 26 Weeks
measure: Intra-Participant Variability in FBG by the Coefficient of Variation
timeFrame: 26 Weeks
measure: Percentage of Participants With Total and Nocturnal Hypoglycemic Events
timeFrame: Baseline through 26 Weeks
measure: Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
timeFrame: 26 Weeks
measure: Percentage of Participants With Injection Site Reactions
timeFrame: Baseline through 26 Weeks
measure: Rate of Severe Hypoglycemic Events
timeFrame: Baseline through 26 Weeks
measure: Percentage of Participants With Severe Hypoglycemic Events
timeFrame: Baseline through 26 Weeks
measure: Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
timeFrame: Baseline, 26 Weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: 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.
state: Arizona
city: Concord
country: United States
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state: California
city: Fresno
country: United States
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state: California
city: Lancaster
country: United States
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state: California
city: Los Angeles
country: United States
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state: California
city: Spring Valley
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Jacksonville
country: United States
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state: Florida
city: Idaho Falls
country: United States
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Des Moines
country: United States
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state: Iowa
city: Topeka
country: United States
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state: Kansas
city: Bloomfield Hills
country: United States
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state: Michigan
city: Nashua
country: United States
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state: New Hampshire
city: Greensboro
country: United States
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state: North Carolina
city: Eugene
country: United States
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state: Oregon
city: Levittown
country: United States
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state: Pennsylvania
city: Greer
country: United States
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state: South Carolina
city: Knoxville
country: United States
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state: Tennessee
city: Spokane
country: United States
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state: Washington
city: Buenos Aires
country: Argentina
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city: Caba
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Spruce Grove
country: Canada
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state: Alberta
city: Burnaby
country: Canada
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state: British Columbia
city: Kelowna
country: Canada
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state: British Columbia
city: St. John
country: Canada
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state: Newfoundland and Labrador
city: Sherbrooke
country: Canada
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state: Quebec
city: Brandys Nad Labem
country: Czechia
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city: Pardubice
country: Czechia
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city: Plzen 2-Slovany
country: Czechia
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city: Prague
country: Czechia
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city: Eisenach
country: Germany
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city: Hohenmölsen
country: Germany
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city: Münster
country: Germany
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city: Saarbrücken
country: Germany
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city: Saint Ingbert-Oberwürzbach
country: Germany
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city: Schkeuditz
country: Germany
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city: Budapest
country: Hungary
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city: Gyongyos
country: Hungary
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city: Nagykanizsa
country: Hungary
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city: Papa
country: Hungary
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city: Bucheon,
country: Korea, Republic of
facility: 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.
city: Daegu
country: Korea, Republic of
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city: Goyang-Si
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Sungnam-Si
country: Korea, Republic of
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city: Guadalajara
country: Mexico
facility: 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.
city: Monterrey
country: Mexico
facility: 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.
city: Gdynia
country: Poland
facility: 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.
city: Krakow
country: Poland
facility: 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.
city: Lodz
country: Poland
facility: 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.
city: Lublin
country: Poland
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city: Szczecin
country: Poland
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city: Las Lomas
country: Puerto Rico
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city: Manati
country: Puerto Rico
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city: San Juan
country: Puerto Rico
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city: Yabucoa
country: Puerto Rico
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city: Alzira
country: Spain
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city: Barcelona
country: Spain
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city: Málaga
country: Spain
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city: Seville
country: Spain
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city: Teruel
country: Spain
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Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern Time (UTC/GMT -5 hours, EST)
role: STUDY_DIRECTOR
References: