Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01474538
First received: November 15, 2011
Last updated: February 4, 2014
Last verified: February 2014

November 15, 2011
February 4, 2014
December 2011
February 2013   (final data collection date for primary outcome measure)
Glycosylated Hemoglobin A1C (HbA1c) at Endpoint [ Time Frame: After 16 weeks of each treatment (Periods1 and 2) ] [ Designated as safety issue: No ]
Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.
Glycosylated Hemoglobin (A1C) at Endpoint [ Time Frame: After 16 weeks of each treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01474538 on ClinicalTrials.gov Archive Site
  • Total Daily Insulin Dose [ Time Frame: Week 16 of each treatment (Periods 1 and 2) ] [ Designated as safety issue: No ]
    Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.
  • Rate of Hypoglycemic Events Per 30 Days [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ] [ Designated as safety issue: Yes ]
    A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).
  • Change From Baseline in Weight [ Time Frame: Baseline, Week 16 of treatment Periods 1 and 2 ] [ Designated as safety issue: Yes ]
    Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.
  • Percentage of Participants With Hypoglycemic Events [ Time Frame: Baseline through 16 weeks of each treatment (Periods 1 and 2) ] [ Designated as safety issue: Yes ]
    A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.
  • Total Daily Insulin Dose [ Time Frame: 16 weeks and 32 weeks ] [ Designated as safety issue: No ]
  • Rate of Hypoglycemic Events per 30 Days [ Time Frame: 16 weeks for each treatment ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Weight [ Time Frame: Baseline, 16 weeks, 32 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Hypoglycemic Events [ Time Frame: 16 weeks for each treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Insulin Lispro Versus Insulin Aspart in Participants With Type 2 Diabetes on Insulin Pump Therapy
A Randomized, Double-Blind, Crossover Trial Comparing the Safety and Efficacy of Insulin Lispro With the Safety and Efficacy of Insulin Aspart in Subjects With Type 2 Diabetes on CSII Therapy

This study will provide information on the use of insulin lispro and insulin aspart in insulin pumps in participants with type 2 diabetes.

This study will provide clinical information on the use of insulin lispro in continuous subcutaneous insulin infusion (CSII) in participants with type 2 diabetes. This study is designed to allow comparison of the 2 rapid-acting insulin analogs, with regard to their efficacy and safety, when used as a pump insulin therapy in this participant population. Each participant will be randomized to 1 of the 2 sequence groups in a 1:1 ratio and randomization will be stratified according to screening A1C (less than or equal to 8.0% or greater than 8.0%) and thiazolidinedione (TZD) use (yes or no). The study design includes the following periods: Screening/Randomization, Treatment Period 1 (16 weeks), and Treatment Period 2 (16 weeks).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Insulin Lispro
    Insulin lispro (100 U/mL) administered by CSII pump
    Other Names:
    • Humalog
    • LY275585
  • Drug: Insulin Aspart
    Insulin aspart (100 U/mL) administered by CSII pump
    Other Name: Novolog
  • Active Comparator: Insulin Lispro, then Insulin Aspart
    Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
    Intervention: Drug: Insulin Lispro
  • Active Comparator: Insulin Aspart, then Insulin Lispro
    Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
    Intervention: Drug: Insulin Aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have type 2 diabetes (per World Health Organization [WHO] Classification of Diabetes)
  • Have been treated with CSII therapy using a rapid-acting analog for the previous 6 months
  • Have a screening A1C less than or equal to 9.0% (no lower limit for A1C)
  • Have a body mass index (BMI) less than 45 kilograms/square meter (kg/m²) at screening
  • Have a history of stable body weight (not varying by greater than 10% for at least 3 months prior to screening)
  • For participants on oral anti-diabetes medications (OAMs): must have been on a stable dose of OAMs, labeled for use with insulin, for at least 3 months prior to study entry

Exclusion Criteria:

  • Have severe insulin resistance [require greater than 2 units/kilogram/day (U/kg/day) of insulin]
  • Are taking or have taken within the last 3 months, antihyperglycemic medication not approved for use with insulin, injectable non-insulin antihyperglycemic medications, or have a contraindication to current antihyperglycemic medication
  • Have a serum creatinine greater than or equal to 2 milligrams/deciliter (mg/dL) if not on metformin; known metabolic or lactic acidosis; any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis; and/or a radiologic contrast study within 48 hours prior to study entry
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intraarticular, and inhaled preparations) or have received such therapy within 2 weeks immediately before screening
  • Have had more than 1 episode of hypoglycemia (defined as requiring assistance of a third party due to disabling hypoglycemia) within 6 months prior to entry into the study
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474538
14207, F3Z-MC-IOQH
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-877-615-4559 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