Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00110370

Purpose

The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Lispro Mixture Therapy Drug: Glargine Basal-Bolus Therapy	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
(A1C less than 7%) with once-daily insulin glargine in combination with OADs.

Secondary Outcome Measures:

To test in both arms the following: frequency and incidence
of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
body weight, SAE's and study drug related AEs.

Estimated Enrollment:	300
Study Start Date:	April 2004
Study Completion Date:	April 2006

Eligibility

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

Criteria

Inclusion Criteria:

Must have type 2 diabetes.
Must be 30-75 years of age at the time of Visit 1.
Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
Must be on at least 30 units of glargine per day at enrollment.
Have an A1C between 7.5% and 12.0% at Visit 1.

Exclusion Criteria:

Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
Must not have more than one episode of severe hypoglycemia in the last 6 months.
Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
Must not have congestive heart failure that requires medications.
Must not have had a kidney transplant or currently receiving dialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110370

Show 48 Study Locations

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 from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

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

Publications indexed to this study:

Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. Epub 2007 Oct 12.

Study ID Numbers:	9057, F3Z-US-IOOQ
Study First Received:	May 6, 2005
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00110370
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009