Official Title: “Twenty-Four-Hour Plasma Glucose Profiles Observed in Patients With Type 2 Diabetes During Therapy Consisting of Oral Agent(s) Plus Twice-Daily Insulin Lispro Low Mixture or Once-Daily Insulin Glargine”

The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

The primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.

Intervention(s) in this Clinical Trial

• Drug: Lispro mix 75/25
  • Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
• Drug: Glargine
  • SC injection, once-daily, given in conjunction with oral antidiabetic medications.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.
• Active Comparator: 2
  • Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

Primary Measures

• Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period.
  • Time Frame: At end of treatment arm or 3 months.
    

Secondary Measures

• HbA1c
  • Time Frame: At end of treatment arm or 3 months.
    
• 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined
  • Time Frame: At end of treatment arm or 3 months.
    
• Plasma glucose AUC excursions during a 24 hours when plasma glucose exceeds the following: greater than or equal to 7.5 mmol/L (135 mg/dL), greater than or equal to 7.8 mmol/L (140 mg/dL), and greater than or equal to 10.0 mmol/L (180 mg/dL)
  • Time Frame: At end of treatment arm or 3 months.
    
• The number of patients with increased plasma glucose during the last 2 hours of each inpatient period
  • Time Frame: At end of treatment arm or 3 months.
    
• The mean amplitude of glycemic excursion
  • Time Frame: At end of treatment arm or 3 months.
    
• Concentration of plasma triglycerides and free fatty acids
  • Time Frame: At end of treatment arm or 3 months.
    
• Self blood glucose monitoring parameters: fasting, premeal, 2 hour postprandial, 2 hour postprandial excursion, bedtime, and overall daily blood glucose value
  • Time Frame: At end of treatment arm or 3 months.
    
• Insulin dose and body weight
  • Time Frame: At end of treatment arm or 3 months.
    

Inclusion Criteria:

• Have type 2 diabetes
• Have inadequate overall glycemic control (hemoglobin A1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to Visit 1
• Have used:
• single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
• insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
• a combination of the above.
• Are greater than or equal to 21 and less than 80 years of age
• As determined by the investigator, are capable and willing to:
• comply with their prescribed diet and medication regimen,
• perform self blood glucose monitoring,
• use the patient diary as required for this protocol,
• participate in two 24 hour inpatient assessments

Exclusion Criteria:

• Have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
• Are currently treated with a meglitinide without sulfonylurea
• Have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
• Have plasma creatinine greater than or equal to 1.5 mg/dL (for males) or greater than or equal to 1.4 mg/dL (for females) for patients who will be treated with metformin or; greater than 2 mg/dL for patients treated with other OAMs, as determined by a local laboratory
• Have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to Visit 1

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00551538

Study ID Number: 7505

ClinicalTrials.gov Identifier: NCT00551538

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry