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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
This study has been completed.
Study NCT00494013   Information provided by Eli Lilly and Company
First Received: June 27, 2007   Last Updated: October 1, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 27, 2007
October 1, 2008
August 2007
Change in Hemoglobin A1c. [ Time Frame: Baseline to twenty four weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00494013 on ClinicalTrials.gov Archive Site
  • Actual and change from baseline HbA1c value at 12 weeks and at endpoint [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c <7.0% and HbA1c < or = 6.5% at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 7-point self-monitored blood glucose (SMBG) profile at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic variability at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence, rate (30-day and 1-year adjusted), and percent reduction (for incidence and rate) of self-reported hypoglycemic episodes (throughout the study and at endpoint), including nocturnal and non-nocturnal; and severe hypoglycemia [ Time Frame: Visits 3, 4, 5, 6, 7, 8, 9, Early Term ] [ Designated as safety issue: Yes ]
  • Absolute body weight (kg) and incremental weight change from baseline to endpoint [ Time Frame: Every office visit, Early Term ] [ Designated as safety issue: Yes ]
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Total daily insulin dose at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of injections of basal insulin analog at endpoint [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Intrapatient glycemic variability as measured from self-monitored blood glucose (SMBG) profiles at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Insulin lispro protamine suspension is non-inferior to insulin detemir as measured by change in absolute body weight (non-inferiority margin of 1.5kg). [ Time Frame: Baseline to 24 weeks. ]
  • Insulin lispro protamine suspension is non-inferior to insulin detemir measured by standard deviation FBG as a measure of intrapatient glycemic variability with a non-inferiority margin of 0.8 mmol/L. [ Time Frame: Measured from self-monitored blood glucose (SMBG) profiles at 24 weeks. ]
  • Insulin lispro protamine suspension is superior to insulin detemir with regard to glycemic control as measured by change in HbA1c from baseline to end point. [ Time Frame: Baseline to 24 weeks. ]
 
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus

The purpose of this study is to examine the effectiveness and safety of lispro suspension as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Diabetes Mellitus Type 2
  • Drug: Insulin Lispro Protamine Suspension
  • Drug: Detemir
  • Experimental: Insulin Lispro Protamine Suspension
  • Active Comparator: Detemir
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
377
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have type 2 diabetes mellitus for at least 1 year.
  2. Are at least 18 years old.
  3. 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, at or above the doses defined in the following: Metformin--1500 mg/day; Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-IV (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
  4. 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. 5.Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m2.

Exclusion Criteria

  1. 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.
  2. 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.
  3. 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.
  4. Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 mg/dL (177 micromol/L).
  5. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Both
18 Years and older
No
 
United States,   Argentina,   Hungary,   India,   Korea, Republic of,   Mexico,   Poland,   Spain,   Taiwan
 
 
NCT00494013
Chief Medical Officer, Eli Lilly
F3Z-MC-IOOY
Eli Lilly and Company
 
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
October 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.