Official Title: “A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70”

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations BID and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Insulin Biphasic Aspart 30/70
  • Patient adjusted dose, Bid, injected SC x 16 weeks
• Drug: Insulin lispro Low Mix
  • Patient adjusted dose, TID, injected SC x 16 weeks
• Drug: Insulin lispro Mid Mix
  • Patient adjusted dose, TID, injected SC x 16 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Insulin lispro LM + insulin lispro MM
• Active Comparator: 2
  • Insulin Biphasic Aspart 30/70

Primary Measures

• To compare efficacy of two insulin treatment strategies in patients with type 2 Diabetes
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Secondary Measures

• Percentage of patients achieving HbA1c <7% and HbA1c </=6.5% in both treatment groups
  • Time Frame: 16 weeks
    Safety Issue?: Yes
• 2-hour postprandial plasma glucose concentrations after the midday meal from self-monitored 7-point plasma glucose
  • Time Frame: 4-8-12-16 weeks
    Safety Issue?: Yes
• Mean 2-hour postprandial blood glucose excursions after midday meal
  • Time Frame: 4-8-12-16 weeks
    Safety Issue?: Yes
• Mean daily blood glucose
  • Time Frame: 2-4-6-8-10-12-16 weeks
    Safety Issue?: Yes
• Incidence and rate of self-reported hypoglycemic episodes
  • Time Frame: 2-4-6-8-10-12-16 weeks
    Safety Issue?: Yes
• Change in weight
  • Time Frame: 16 weeks
    Safety Issue?: No
• Compare the total daily insulin dose in the treatment groups
  • Time Frame: 16 weeks
    Safety Issue?: No

Inclusion Criteria:

• Have type 2 diabetes (World Health Organization [WHO] classification).
• Are at least 30 years of age and less than 75 years of age.
• Have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro LM or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 mg of metformin per day for at least 60 days immediately prior to the study.
• Have a hemoglobin A1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at Visit 1 or Have at least 6 of 9 of the postprandial blood glucose values recorded in the period between Visit 1 and Visit 2 exceeding 180 mg/dl
• [10.0 mmol/l]. accordance with local regulations.

Exclusion Criteria:

• Are taking any other OAMs not mentioned in inclusion criterion [3].
• Have a body mass index greater than 40 kg/m2.
• Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
• Have congestive heart failure.
• Have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).

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 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393705

Study ID Number: 10916

ClinicalTrials.gov Identifier: NCT00393705

Health Authority: Poland: Ministry of Science and Higher Education

Lilly Clinical Trial Registry