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

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: insulin lispro LM; Drug: insulin lispro MM; Drug: Insulin Biphasic Aspart 30/70

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393705

10916

F3Z-VI-S019 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

insulin lispro LM + insulin lispro MM

Experimental group

Description:

Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.

Treatment:

Drug: insulin lispro MM

Drug: insulin lispro LM

Drug: insulin lispro LM

Insulin Biphasic Aspart 30/70 or Insulin Lispro LM

Active Comparator group

Description:

Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment).

Treatment:

Drug: Insulin Biphasic Aspart 30/70

Drug: insulin lispro LM

Drug: insulin lispro LM