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Lispro Mix 25 vs. Glargine in Type 2 Diabetics (IOOL)
This study has been completed.
Study NCT00551356   Information provided by Eli Lilly and Company
First Received: October 29, 2007   No Changes Posted

October 29, 2007
October 29, 2007
November 2002
 
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast [ Time Frame: 16 weeks or end of study. ]
Same as current
No Changes Posted
  • Hemoglobin A1c measured at endpoint [ Time Frame: 16 weeks or end of study. ]
  • Change of hemoglobin A1c from baseline to endpoint [ Time Frame: 16 weeks or end of study. ]
  • Glycemic control as determined by self-monitored blood glucose concentrations [ Time Frame: 16 weeks or end of study. ]
  • The incidence and rate of self-reported hypoglycemic episodes [ Time Frame: 16 weeks or end of study. ]
  • Body mass index (BMI) [ Time Frame: 16 weeks or end of study. ]
  • Body weight [ Time Frame: 16 weeks or end of study. ]
  • Total Insulin Doses [ Time Frame: 16 weeks or end of study. ]
Same as current
 
Lispro Mix 25 vs. Glargine in Type 2 Diabetics
Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Diabetes Mellitus Type 2
  • Drug: Insulin lispro mix 25
  • Drug: Glargine
  • Active Comparator: Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
  • Active Comparator: Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
53
July 2003
 

Inclusion Criteria:

  • Males or females who have type 2 diabetes between 1 and 10 years
  • Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
  • Have not been on insulin treatment within 3 months before entry into the study
  • Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
  • Have a body mass index below 40 kg/m²

Exclusion Criteria:

  • Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
  • Have a known allergy to insulin
  • Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
  • Have known proliferative retinopathy
  • Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00551356
 
7354, F3Z-ME-IOOL
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 2007

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