Lispro Mix 25 vs. Glargine in Type 2 Diabetics

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Glargine; Drug: Insulin lispro mix 25

• Registration Number: NCT00551356
• Lead Sponsor: Eli Lilly and Company

Brief 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.

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 Timeline

• Study Start: 2002-11
• Study Completion: 2003-07
• Status Verified: 2007-10
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Last Update Submitted: 2007-10-29
• Study First Posted: 2007-10-31
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Glargine	Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
1	Insulin lispro mix 25	Lispro mix 25 SC twice-daily in conjunction with oral antidiabetic medications.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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, Mexico