Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

• Change in the HbA1c concentration from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
• Proportion of patients who achieve a target HbA1c concentration of less than7% or less than or equal to 6.5% at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Change in the fasting plasma glucose concentration from baseline to 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
• 7-point self-monitored blood glucose (SMBG) profiles at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
• Glycemic variability from the 7-point SMBG profiles at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
• Daily insulin dose: total, basal, and prandial at 12 weeks and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
• Change in weight from baseline to 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
• The incidence of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
• Insulin Treatment Satisfaction Questionnaire (ITSQ) score at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Perceptions about Medications-Diabetes 21 (PAM-D21) questionnaire score at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• The rate of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]
• The severity of hypoglycemic episodes [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]

The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in patients with Type 2 Diabetes.

• Drug: Insulin Lispro
  Patient dependent dose, administered subcutaneously for 24 weeks
  Other Names:

  • Humalog
  • Humalog Mix75/25
  • LY275585
• Drug: Insulin Glargine
  Patient dependent dose, administered subcutaneously for 24 weeks

• Experimental: Insulin lispro low mixture
  Two daily injections (breakfast and dinner) of insulin lispro mix 75/25
  Intervention: Drug: Insulin Lispro
• Active Comparator: Insulin glargine+insulin lispro
  Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro
  Interventions:

  • Drug: Insulin Lispro
  • Drug: Insulin Glargine

Inclusion Criteria:

• Present with type 2 diabetes mellitus
• Have been taking metformin and/or pioglitazone
• Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
• Have HbA1c concentration between greater than or equal to 7.5% and less than or equal to 10.5
• Have a fasting plasma glucose concentration of less than or equal to 6.7 mmol/L (less than or equal to 121 mg/dL), or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
• Not pregnant or breastfeeding

Exclusion Criteria:

• Have Type 1 Diabetes
• Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
• Have a body mass index (BMI) greater than 45 kg/m2.
• Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
• Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
• Have cardiac disease with a functional status that is Class III or IV
• Have a history of renal or liver disease
• Have had a blood transfusion or have a blood disorder