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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) (IOPE)

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ClinicalTrials.gov Identifier: NCT00510952
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : November 3, 2009
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE August 1, 2007
First Posted Date  ICMJE August 3, 2007
Results First Submitted Date  ICMJE September 25, 2009
Results First Posted Date  ICMJE November 3, 2009
Last Update Posted Date October 21, 2010
Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 24 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
Change in Hemoglobin A1c from baseline to 24 weeks. [ Time Frame: Baseline to 24 weeks ]
Change History Complete list of historical versions of study NCT00510952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value [ Time Frame: Baseline, 12 Weeks, 24 Weeks ]
  • Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint [ Time Frame: 24 weeks ]
    Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.
  • Glycemic Variability at Endpoint [ Time Frame: 24 weeks ]
    Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.
  • 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint [ Time Frame: 24 weeks ]
    Actual measurements and daily mean blood glucose levels at endpoint.
  • Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall [ Time Frame: Baseline to 24 weeks ]
    Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
  • 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 weeks ]
    Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
  • 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall [ Time Frame: Baseline to 24 Weeks ]
    Overall: any time after randomization. Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL. Nocturnal: any hypoglycemic event that occurred between bedtime and waking. Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
  • Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint [ Time Frame: Baseline, 24 weeks ]
  • Total Daily Insulin Dose (Units) at Endpoint [ Time Frame: 24 weeks ]
    Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
  • Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint [ Time Frame: 24 Weeks ]
    Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2007)
  • Actual and change from baseline HbAlc value. [ Time Frame: At weeks 12 and 24 ]
  • Percentage of patients with HbAlc less than 7.0 percent and HbAlc less than or equal to 6.5 percent at endpoint. [ Time Frame: 24 weeks ]
  • 7-point self-monitored blood glucose (SMBG) profile and glycemic variability from these profiles at endpoint. [ Time Frame: 24 weeks ]
  • The incidence, 30 day adjusted rate, and 1 year adjusted rate of reported hypoglycemic episodes (throughout the study and at endpoint) including nocturnal and non-nocturnal; and severe hypoglycemia. [ Time Frame: 24 weeks ]
  • Absolute body weight (kg) and incremental weight change from baseline to endpoint. [ Time Frame: 24 weeks ]
  • Treatment-emergent adverse events (TEAEs). [ Time Frame: 24 weeks ]
  • Total daily insulin dose. [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE)
Official Title  ICMJE The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications
Brief Summary The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Insulin Lispro Protamine Suspension
    Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
    Other Names:
    • Insulin Lispro Protamine Suspension (ILPS)
    • Neutral Protamine Lispro (NPL)
    • Humalog
  • Drug: Insulin Glargine
    Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
Study Arms  ICMJE
  • Experimental: Lispro
    Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
    Intervention: Drug: Insulin Lispro Protamine Suspension
  • Active Comparator: Glargine
    Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
    Intervention: Drug: Insulin Glargine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2009)
471
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2007)
378
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have type 2 diabetes mellitus for at least 1 year.
  • Are greater than or equal to 18 years old.
  • Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
  • Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
  • Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.

Exclusion Criteria:

  • Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
  • Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
  • Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
  • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
  • Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Puerto Rico,   United States
Removed Location Countries Argentina,   India,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain
 
Administrative Information
NCT Number  ICMJE NCT00510952
Other Study ID Numbers  ICMJE 11813
F3Z-MC-IOPE ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date October 2010

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