A Study in Adults With Type 1 Diabetes (ELEMENT 1)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01421147
First received: August 19, 2011
Last updated: April 24, 2013
Last verified: April 2013

August 19, 2011
April 24, 2013
August 2011
August 2012   (final data collection date for primary outcome measure)
Change from baseline up to 24 weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01421147 on ClinicalTrials.gov Archive Site
  • Change from baseline in insulin antibody levels [ Time Frame: Baseline, 6 weeks, 12 weeks, up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Rate per 30 days of hypoglycemic episodes [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: Baseline, 6 weeks, 12 weeks, 36 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • 7-point self-monitored blood glucose (SMBG) profiles [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with HbA1c <7% and HbA1c ≤6.5% [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic variability of fasting blood glucose [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose per Body Weight (U/kg) (Total and by Component [Basal and Bolus]) [ Time Frame: Up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose - Units (Total and by Component [Basal and Bolus]) [ Time Frame: Up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks, up to 24 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey (ALBSS) [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycemic Events [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study in Adults With Type 1 Diabetes
A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: LY2963016
    Administered subcutaneously
  • Drug: Lantus
    Administered subcutaneously
  • Drug: Insulin Lispro
    Administered subcutaneously
  • Experimental: LY2963016 + Insulin Lispro
    LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with premeal insulin lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks
    Interventions:
    • Drug: LY2963016
    • Drug: Insulin Lispro
  • Active Comparator: Lantus + Insulin Lispro
    Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with premeal insulin lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks
    Interventions:
    • Drug: Lantus
    • 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
400
April 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have Type 1 Diabetes Mellitus based on the disease diagnostic criteria (World Health Organization [WHO] Classification)
  • Have duration of diabetes greater than or equal to one year
  • Have HbA1c less than or equal to 11.0%
  • On basal-bolus insulin therapy for at least 1 year (basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine)
  • Have a body mass index (BMI) of less than or equal to 35 kg/m^2

Exclusion Criteria:

  • Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
  • Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
  • Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
  • Have significant renal, cardiac, gastrointestinal or liver disease
  • Have active cancer or cancer within the past 5 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Greece,   Hungary,   Japan,   Mexico,   Poland,   Romania
 
NCT01421147
13712, I4L-MC-ABEB, 2011-000829-73
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
April 2013

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