Lispro Mix 25 vs. Glargine in Type 2 Diabetics (IOOL)

Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Glargine; Drug: Insulin lispro mix 25

Detailed Description

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females who have type 2 diabetes between 1 and 10 years
• Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
• Have not been on insulin treatment within 3 months before entry into the study
• Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
• Have a body mass index below 40 kg/m²

Exclusion Criteria:

• Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
• Have a known allergy to insulin
• Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
• Have known proliferative retinopathy
• Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.	Drug: Glargine; Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.; Other Names: Lantus
Active Comparator: 1; Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.	Drug: Insulin lispro mix 25; Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.; Other Names: Humalog Mix25

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast	16 weeks or end of study.

Secondary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c measured at endpoint	16 weeks or end of study.
Change of hemoglobin A1c from baseline to endpoint	16 weeks or end of study.
Glycemic control as determined by self-monitored blood glucose concentrations	16 weeks or end of study.
The incidence and rate of self-reported hypoglycemic episodes	16 weeks or end of study.
Body mass index (BMI)	16 weeks or end of study.
Body weight	16 weeks or end of study.
Total Insulin Doses	16 weeks or end of study.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: October 29, 2007
• First Submitted That Met QC Criteria: October 29, 2007
• First Posted (Estimate): October 31, 2007

Study Record Updates

• Last Update Posted (Estimate): October 31, 2007
• Last Update Submitted That Met QC Criteria: October 29, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Diabetic; Lispro; Glargine; Humalog; Lantus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 7354; F3Z-ME-IOOL