A Study in Patients With Type I Diabetes Mellitus (IMAGINE 3)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01454284
First received: October 14, 2011
Last updated: April 14, 2014
Last verified: February 2014

October 14, 2011
April 14, 2014
January 2012
February 2014   (final data collection date for primary outcome measure)
Hemoglobin A1c (HbA1c) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01454284 on ClinicalTrials.gov Archive Site
  • Rate of total hypoglycemia events [ Time Frame: 0 to 26 weeks, 0 to 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HbA1c equal or less than 6.5% and less than 7.0 % [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Fasting serum glucose (by laboratory measurement) [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • 9 point self-monitored blood glucose (SMBG) [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 weeks in HbA1c [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Basal, meal time, and total insulin dose per body weight [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • European Quality of Life -5 dimension (EuroQol-5 dimension) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Triglycerides, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in anti-LY2605541 antibodies [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Intra-patient variability of fasting blood glucose (FBG) [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of total hypoglycemic events [ Time Frame: 0-26 weeks, 0-52 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with HbA1c less than 7.0 % and without nocturnal hypoglycemia [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Rapid Assessment of Physical Activity (RAPA) [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Fasting blood glucose (by participant self monitored blood glucose readings) [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of nocturnal hypoglycemic events [ Time Frame: 0-26 weeks, 0-52 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin A1c (HbA1c) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • 0300 hours blood glucose (BG) to fasting BG excursion [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study in Patients With Type I Diabetes Mellitus
The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

The purpose of this study is:

  • To compare the blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
  • To compare the number of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
  • To compare the number of patients on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
  • To compare the total number of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: Glargine
    Administered by subcutaneous injection
  • Drug: LY2605541
    Administered by subcutaneous injection.
  • Drug: Insulin Lispro
    Administered subcutaneously
    Other Names:
    • LY275585
    • Humalog
  • Experimental: LY2605541 + Insulin Lispro
    LY2605541 titrated based on blood glucose readings, administered subcutaneously once daily at bedtimes for 52 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously at meal times for 52 weeks.
    Interventions:
    • Drug: LY2605541
    • Drug: Insulin Lispro
  • Active Comparator: Glargine + Insulin Lispro
    Glargine dose titrated based on blood glucose readings, administered subcutaneously once daily at bedtimes for 52 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered subcutaneously at meal times for 52 weeks.
    Interventions:
    • Drug: Glargine
    • Drug: Insulin Lispro
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1113
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes for at least 1 year
  • HbA1c value less than 12 percent according to the central laboratory at screening
  • body mass index of less than or equal to 35.0 kg/m^2
  • Have been treated for at least 90 days prior to screening with

    • insulin detemir, insulin glargine, or Neutral Protamine Hagedorn (NPH)in combination with pre-meal insulin, or
    • self mixed or pre-mixed insulin regimens with any basal and bolus insulin combination administered at least twice daily, or
    • continuous subcutaneous insulin infusion therapy
  • Women who are not breast feeding and test negative for pregnancy before receiving treatment and agree to use reliable birth control until 4 weeks after last treatment with study drug
  • Are capable and willing to adhere to multiple daily injections, inject with a vial and syringe and prefilled pen and perform self monitored blood glucose readings and record keeping

Exclusion Criteria:

  • Are using twice daily insulin glargine having been inadequately controlled on single daily dose of glargine prior to screening
  • Excessive insulin resistance defined as having received a total daily dose of insulin greater than 1.5 U/kg at the time of randomization
  • Receiving any oral or injectable medication (other than insulins or metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus in the 90 days prior to screening
  • Lipid lowering medications:

    • are using niacin preparations as 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 or more prior to screening
    • Have fasting hypertriglyceridemia (defined as greater than 4.5 mmol/L, greater than 400 mg/dl) at screening, as determined by the central laboratory.
    • Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening
    • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control 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 2.5 mg/dL
    • 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 2 times or more than the upper limit of normal (ULN) as defined by the central laboratory, or
    • alanine aminotransferase (ALT)/(serum glutamic pyruvic transaminase (SGPT) more than 2.5 times ULN as defined by the central laboratory, or
    • aspartate aminotransferase (AST)/(serum glutamic oxaloacetic transaminase (SGOT) more than 2.5 times 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
    • Diagnosed clinically significant diabetic autonomic neuropathy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   Croatia,   Denmark,   France,   Greece,   Ireland,   Israel,   Lithuania,   Netherlands,   New Zealand,   Poland,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01454284
12147, I2R-MC-BIAO, 2011-001253-82
Yes
Eli Lilly and Company
Eli Lilly and Company
Boehringer Ingelheim
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
Eli Lilly and Company
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP