Official Title: “Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast”

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Study Type: Interventional

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

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Drug: Insulin Glargine
  • patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks
• Drug: Insulin Lispro Premix (mid-mixture and low-mixture)
  • patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Glargine +/- 1,2 or 3 injections of insulin lispro plus OAMs
• Experimental: 2
  • Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs

Primary Measures

• Baseline adjusted HbA1c at endpoint
  • Time Frame: 48 weeks
    Safety Issue?: No

Secondary Measures

• Percentage of patients using each possible final insulin regimen
  • Time Frame: 48 weeks
    Safety Issue?: No
• Mean change in HbA1c overtime
  • Time Frame: 16 weeks, 32 weeks, and 48 weeks
    Safety Issue?: No
• Percentage of patients achieving HbA1c less than or equal to 6.5% and less than 7% over time
  • Time Frame: 16 weeks, 32 weeks and 48 weeks
    Safety Issue?: No
• 7-point self-monitored blood glucose profiles
  • Time Frame: Baseline, 16 weeks, 32 weeks and 48 weeks
    Safety Issue?: No
• Mean change from baseline in postprandial blood glucose
  • Time Frame: 16 weeks, 32 weeks and 48 weeks
    Safety Issue?: No
• Mean daily total, basal and prandial insulin dose
  • Time Frame: 16 weeks, 32 weeks and 48 weeks
    Safety Issue?: No
• Body weight change
  • Time Frame: From baseline to endpoint
    Safety Issue?: Yes
• Incidence and rate of all self-reported hypoglycemic episodes
  • Time Frame: Baseline to 48 weeks
    Safety Issue?: Yes
• Incidence of treatment-emergent adverse events
  • Time Frame: Baseline to 48 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• have been receiving metformin plus at least one other oral antihyperglycemic medication (sulfonylurea or TZD) without insulin, for at least 90 days prior to Visit 1
• HbA1c greater than or equal to 7.0% and less than 11.0%
• regularly consume a light breakfast (less than 15% of total daily calorie intake)
• capable and willing to follow the protocol
• give written consent

Exclusion Criteria:

• are taking a TZD whose country label does not allow in combination with insulin
• are taking any glucose-lowering agents (other than specified in the

  inclusion criteria

• above)
• have a body mass index greater than 40 kg/m2
• have a history of severe hypoglycemia in past 24 weeks
• are pregnant or may become pregnant
• women who are breastfeeding
• have significant cardiac disease
• have significant renal or liver disease
• undergoing therapy for a malignancy
• contraindications to study medications
• have an irregular sleep/wake cycle

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 74 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  

Overall Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664534

Study ID Number: 11806

ClinicalTrials.gov Identifier: NCT00664534

Health Authority: Romania: National Medicines Agency

Lilly Clinical Trial Registry