Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Biphasic Aspart 30/70; insulin lispro LM; insulin lispro MM; insulin lispro LM
Intervention description: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks; Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.; Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks; Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; type 2

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.
    

Eligibility 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).