Lispro Mix 25 vs. Glargine in Type 2 Diabetics - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00551356

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: Insulin lispro mix 25 Drug: Glargine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	53
Study Start Date:	November 2002
Study Completion Date:	July 2003

Arms	Assigned Interventions
2: Active Comparator 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.
1: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551356

Locations

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, Mexico

Sponsors and Collaborators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	7354, F3Z-ME-IOOL
Study First Received:	October 29, 2007
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00551356 History of Changes
Health Authority:	Mexico: Instituto Mexicano de Investigacion Clinica

Keywords provided by Eli Lilly and Company:

Diabetes
Diabetic
Insulin
Humalog

Lantus
Glargine
Lispro

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Insulin LISPRO
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 27, 2009