Lispro Mix 25 vs. Glargine in Type 2 Diabetics

Diabetes Mellitus Type 2 Clinical Trial

— IOOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551356
• Other study ID #: 7354
• Secondary ID: F3Z-ME-IOOL
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2007
• Last updated: October 29, 2007
• Start date: November 2002
• Est. completion date: July 2003

Study information

• Verified date: October 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Instituto Mexicano de Investigacion Clinica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin lispro mix 25
Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.
• Glargine
Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.

Locations

Country	Name	City	State
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.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast		16 weeks or end of study.
Secondary	Hemoglobin A1c measured at endpoint		16 weeks or end of study.
Secondary	Change of hemoglobin A1c from baseline to endpoint		16 weeks or end of study.
Secondary	Glycemic control as determined by self-monitored blood glucose concentrations		16 weeks or end of study.
Secondary	The incidence and rate of self-reported hypoglycemic episodes		16 weeks or end of study.
Secondary	Body mass index (BMI)		16 weeks or end of study.
Secondary	Body weight		16 weeks or end of study.
Secondary	Total Insulin Doses		16 weeks or end of study.

External Links

•   Lilly Clinical Trial Registry