Lispro Mix 25 vs. Glargine in Type 2 Diabetics

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Insulin lispro mix 25
  • Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
• Drug: Glargine
  • Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
• Active Comparator: 1
  • Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.

Primary Measures

• Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
  • Time Frame: 16 weeks or end of study.
    

Secondary Measures

• 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.
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00551356

Study ID Number: 7354

ClinicalTrials.gov Identifier: NCT00551356

Health Authority: Mexico: Instituto Mexicano de Investigacion Clinica

Lilly Clinical Trial Registry