Clinical trial NCT01468987: A Study in Participants With Type 2 Diabetes Mellitus
Official title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 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: 2011-11-10
Enrollment: 1369
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 blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
* To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
* To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.


Eligibility criteria: Inclusion Criteria

* Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
* Had diabetes ≥1 year
* Have a hemoglobin A1c (HbA1c) value ≥7.0% and \<12.0% at screening
* Have a body mass index (BMI) ≤45.0 kilograms per square meter (kg/m\^2)
* Participants on any glucose lowering regimen that contains at least 1 daily insulin injection
* This inclusion criterion applies ONLY to women of childbearing potential

  * Are not breastfeeding
  * Test negative for pregnancy at screening and randomization
  * Do not intend to become pregnant during the study
  * Have practiced a reliable method of birth control for at least 6 weeks prior to screening
  * Agree to continue to use a reliable method of birth control during the study, as determined by the investigator (and for 2 weeks following the last dose of study drug)
* Have access to a method of communication with the site
* Have refrigeration in the home
* Capable of, and willing to do the following: adhere to a multiple daily injection regimen, inject insulin with a covered vial and syringe and prefilled pen, attend some appointments in the fasting state, and perform self blood glucose monitoring and record keeping as required by this protocol, as determined by the investigator. Caregiver may be responsible for all of the above
* Have given written informed consent to participate in this study in accordance with local regulations

Exclusion Criteria

* Continuous subcutaneous insulin infusion therapy prior to screening
* Are using twice daily insulin glargine prior to screening
* Excessive insulin resistance defined as having received a daily dose of insulin ≥2.0 units per kilogram (units/kg) at the time of pre-randomization
* Glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening
* Are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening; or, are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening
* Have fasting hypertriglyceridemia (defined as \>4.5 millimoles per liter \[mmol/L\], \>400 milligrams per deciliter \[mg/dL\]) at screening
* Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
* Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
* Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
* Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
* 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 as indicated below:

  * total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
  * alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \>2.5X ULN as defined by the central laboratory, or
  * aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \>2.5X ULN as defined by the central laboratory
* Have active or untreated malignancy, have been in remission from clinically significant malignancy (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 or develop hypersensitivity or allergy to any of the study insulins or their excipients
* 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 HbA1c measurement
* Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
* Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
* Have had an organ transplant
* Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: Total Hypoglycemia Rates (Adjusted for 30 Days)
timeFrame: Baseline through 26 weeks
measure: Percentage of Participants With Total Hypoglycemia Episodes
timeFrame: Baseline through 26 weeks
measure: Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
timeFrame: Baseline through 26 weeks
measure: Percentage of Participants With Nocturnal Hypoglycemia Episodes
timeFrame: Baseline through 26 weeks
measure: Body Weight Change From Baseline to 26 Weeks
timeFrame: Baseline, 26 weeks
measure: Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
timeFrame: 26 weeks
measure: Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
timeFrame: up to 26 weeks
measure: Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
timeFrame: up to 26 weeks
measure: Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
timeFrame: 26 weeks
measure: Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
timeFrame: 26 weeks
measure: Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
timeFrame: 26 weeks
measure: 0300-hour Blood Glucose to FBG Excursion at 26 Weeks
timeFrame: 26 weeks
measure: HbA1c at 26 Weeks
timeFrame: 26 weeks
measure: Lipid Profile at 26 Weeks
timeFrame: 26 weeks
measure: Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
timeFrame: Baseline through 26 weeks
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
timeFrame: up to 26 weeks
measure: Low Blood Sugar Survey (LBSS) at 26 Weeks
timeFrame: 26 weeks
measure: EuroQoL-5D (EQ-5D) at 26 Weeks
timeFrame: up to 26 weeks
measure: Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
timeFrame: up to 26 weeks
Other outcomes:
Locations:
city: Mobile
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: Alabama
city: Tucson
country: United States
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state: Arizona
city: Little Rock
country: United States
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state: Arkansas
city: Anaheim
country: United States
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state: California
city: Chino
country: United States
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state: California
city: Concord
country: United States
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state: California
city: Fresno
country: United States
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state: California
city: La Mesa
country: United States
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state: California
city: Lancaster
country: United States
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state: California
city: Mission Hills
country: United States
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state: California
city: Tustin
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state: California
city: Longmont
country: United States
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state: Colorado
city: Daytona Beach
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: West Palm Beach
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state: Florida
city: Winter Haven
country: United States
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state: Florida
city: Atlanta
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
city: Springfield
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state: Illinois
city: Des Moines
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state: Iowa
city: Topeka
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state: Kansas
city: Lexington
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state: Kentucky
city: Bangor
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state: Maine
city: Baltimore
country: United States
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state: Maryland
city: Eagan
country: United States
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state: Minnesota
city: Jefferson City
country: United States
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state: Missouri
city: Saint Louis
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state: Missouri
city: Billings
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state: Montana
city: Omaha
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state: Nebraska
city: Las Vegas
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state: Nevada
city: Nashua
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state: New Hampshire
city: Toms River
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state: New Jersey
city: New York
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state: New York
city: Morehead City
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state: North Carolina
city: Fargo
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state: North Dakota
city: Cleveland
country: United States
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state: Ohio
city: Columbus
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state: Ohio
city: Mentor
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state: Ohio
city: Pittsburgh
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state: Pennsylvania
city: Greer
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Austin
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Renton
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Tacoma
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state: Washington
city: Camperdown
country: Australia
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state: New South Wales
city: St Leonards
country: Australia
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state: New South Wales
city: Daw Park
country: Australia
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state: South Australia
city: East Ringwood
country: Australia
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state: Victoria
city: Geelong
country: Australia
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state: Victoria
city: Parkville
country: Australia
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state: Victoria
city: Fremantle
country: Australia
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state: Western Australia
city: Graz
country: Austria
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city: Vienna
country: Austria
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city: Aparecida De Goiania
country: Brazil
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city: Brasilia
country: Brazil
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city: Cakovec
country: Croatia
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city: Osijek
country: Croatia
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city: Rijeka
country: Croatia
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city: Slavonski Brod
country: Croatia
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city: Varazdin
country: Croatia
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city: Zagreb
country: Croatia
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city: Holesov
country: Czechia
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city: Hranice I-Mesto
country: Czechia
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city: Krnov
country: Czechia
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city: Pardubice
country: Czechia
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city: Prague
country: Czechia
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city: Esbjerg
country: Denmark
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city: Hillerod
country: Denmark
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city: Kobenhavn
country: Denmark
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city: Berlin
country: Germany
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city: Burghausen
country: Germany
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city: Eisenach
country: Germany
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city: Essen
country: Germany
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city: Falkensee
country: Germany
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city: Mainz
country: Germany
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city: Mayen
country: Germany
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city: Münster
country: Germany
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city: Neuwied
country: Germany
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city: Ampelokipoi
country: Greece
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city: Athens
country: Greece
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city: Nikaias - Piraeus
country: Greece
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city: Thessaloniki
country: Greece
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city: Bekescsaba
country: Hungary
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city: Budapest
country: Hungary
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city: Gyula
country: Hungary
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city: Veszprem
country: Hungary
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city: Zalaegerszeg
country: Hungary
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city: Beer Sheva
country: Israel
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city: Holon
country: Israel
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city: Jerusalem
country: Israel
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city: Nahariya
country: Israel
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city: Safed
country: Israel
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city: Tel Hashomer
country: Israel
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city: Bergamo
country: Italy
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city: Bologna
country: Italy
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city: Olbia
country: Italy
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city: Pavia
country: Italy
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city: Rozzano
country: Italy
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Tokyo
country: Japan
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city: Kaunas
country: Lithuania
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city: Klaipeda
country: Lithuania
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city: Monterrey
country: Mexico
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city: Queretaro
country: Mexico
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city: Tampico
country: Mexico
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city: Dordrecht
country: Netherlands
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city: Groningen
country: Netherlands
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city: Heerlen
country: Netherlands
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city: Hoogeveen
country: Netherlands
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city: Leiden
country: Netherlands
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city: Krakow
country: Poland
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city: Lublin
country: Poland
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city: Sopot
country: Poland
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city: Szczecin
country: Poland
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city: Wroclaw
country: Poland
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city: Caguas
country: Puerto Rico
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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: Brasov
country: Romania
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city: Cluj
country: Romania
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city: Oradea
country: Romania
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city: Ploiesti
country: Romania
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city: Satu Mare
country: Romania
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city: Arkhangelsk
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Rostov-On-Don
country: Russian Federation
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city: Saint Petersburg
country: Russian Federation
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city: Dolny Kubin
country: Slovakia
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city: Kosice
country: Slovakia
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city: Lubochna
country: Slovakia
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city: Roznava
country: Slovakia
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city: Barcelona
country: Spain
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city: Málaga
country: Spain
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city: Sabadell
country: Spain
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city: Sevilla
country: Spain
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city: Seville
country: Spain
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city: Chiayi City
country: Taiwan
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city: Sindian City
country: Taiwan
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city: Taichung
country: Taiwan
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city: Yong Kung City
country: Taiwan
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city: Ankara
country: Turkey
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city: Diyarbakir
country: Turkey
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city: Istanbul
country: Turkey
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city: Kayseri
country: Turkey
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city: Kutahya
country: Turkey
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city: Middlesbrough
country: United Kingdom
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state: Cleveland
city: Leicester
country: United Kingdom
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state: Leicestershire
city: Edinburgh
country: United Kingdom
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state: Scotland
city: Guildford
country: United Kingdom
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state: Surrey
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: