Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane

Criteria

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 milligrams (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 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter [mmol/l]).

• Have given written informed consent to participate in this study in accordance with local regulations.

Exclusion Criteria:

• Are taking any other oral anti-diabetic medication (OAM) not mentioned in inclusion criterion.

• Have a body mass index greater than 40 kilograms per meter squared (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).