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
  Purpose

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

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Glargine
Drug: LY2605541
Drug: Insulin Lispro
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1113
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: LY2605541
Administered by subcutaneous injection.
Drug: Insulin Lispro
Administered subcutaneously
Other Names:
  • LY275585
  • Humalog
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.
Drug: Glargine
Administered by subcutaneous injection
Drug: Insulin Lispro
Administered subcutaneously
Other Names:
  • LY275585
  • Humalog

  Eligibility

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

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
  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: NCT01454284

  Show 119 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: NCT01454284     History of Changes
Other Study ID Numbers: 12147, I2R-MC-BIAO, 2011-001253-82
Study First Received: October 14, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
France: Ministry of Health
Greece: Ministry of Health and Welfare
Ireland: Irish Medicines Board
Israel: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Slovenia: Ministry of Health
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin LISPRO
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014