A Study in Participants With Type 2 Diabetes Mellitus (IMAGINE 4)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01468987
First received: November 8, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of this study is:

  • To compare blood sugar control on LY2605541 with insulin glargine after 26 weeks of treatment.
  • To compare the number of night time low blood sugar episodes on LY2605541 with insulin glargine during 26 weeks of treatment.
  • To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 26 weeks of treatment.
  • To compare the total number of low blood sugar episodes on LY2605541 with insulin glargine after 26 weeks of treatment.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2605541
Drug: Insulin Glargine
Drug: Insulin Lispro
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1c (HbA1c) at 26 weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nocturnal hypoglycemia rates (Adjusted for 30 days) [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with total hypoglycemia episodes [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]
  • Weight change from baseline to 26 weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Self Monitored Blood Glucose (SMBG) 9-point profiles at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HbA1c <7.0% and ≤6.5% at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HbA1c <7.0% without nocturnal hypoglycemia at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Basal, bolus, and total insulin dose by weight at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose (FSG) from laboratory at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • FBG (SMBG) intra-participant variability at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • 0300-hour blood glucose (BG) to FBG excursion at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • HbA1c at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Lipid profile at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with change in anti-LY2605541 antibodies from baseline to 26 weeks [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: Yes ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Low Blood Sugar Survey (LBSS) at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • EuroQoL-5D (EQ-5D) at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Rapid Assessment of Physical Activity (RAPA) at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Total hypoglycemia rates (Adjusted for 30 days) [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with nocturnal hypoglycemia episodes [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1325
Study Start Date: December 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin Glargine + Insulin Lispro

Participant-specific dose of Insulin Glargine will be administered subcutaneously once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro will be administered subcutaneously for preprandial and supplemental doses for 26 weeks.

Drug: Insulin Glargine
- Administered by subcutaneous injection
Drug: Insulin Lispro
- Administered subcutaneously
Other Name: Humalog
Experimental: LY2605541 + Insulin Lispro

Participant-specific dose of LY2605541 will be administered subcutaneously once daily at bedtime for 26 weeks.

Participant-specific dose of Insulin Lispro will be administered subcutaneously for preprandial and supplemental doses for 26 weeks.

Drug: LY2605541
- Administered by subcutaneous injection
Drug: Insulin Lispro
- Administered subcutaneously
Other Name: Humalog

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Have Type 2 Diabetes Mellitus based on the World Health Organization (WHO) classification
  • Had diabetes ≥1 year
  • Have an HbA1c value ≥7.0% and <12.0% at screening
  • Have a Body Mass Index (BMI) ≤45.0 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/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 mmol/L, >400 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468987

  Show 156 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01468987     History of Changes
Other Study ID Numbers: 12145, I2R-MC-BIAM, 2011-001254-29
Study First Received: November 8, 2011
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Ministry of Health
Spain: Ministry of Health
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014