Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: premeal insulin lispro mixtures (Drug); insulin glargine (Drug); metformin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The primary objective of this study is to show that a prandial insulin regimen, consisting of
premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture"
and insulin lispro "low mixture") plus metformin will result in significantly better overall
glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin.
Insulin lispro "mid mixture" consists of 50% insulin lispro and 50% NPL. Insulin lispro "low
mixture" consists of 25% insulin lispro and 75% NPL.
In a substudy of approximately 60 patients, additional data will be collected on markers
associated with risk of atherosclerosis or cardiovascular disease in the context of a
controlled, outpatient, high-fat test meal.
Clinical Details
Official title: Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes: A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: HbA1C
Secondary outcome: General inflammation (hsCRP)High-density lipoprotein cholesterol Total cholesterol Triglycerides Estimates of low-density lipoprotein cholesterol Nuclear magnetic resonance [NMR] analysis of lipids Oxidized LDL Lipoproteins and apoproteins Fibrinogen Blood glucose levels (based on self-monitoring) Insulin dose Weight Frequency and incidence of hypoglycemia Safety General well-being Pilot two questionnaires for microvascular complications Coagulopathy factors [substudy] Surrogate measure of vascular reactivity [substudy] Inflammatory markers [substudy] Production of advanced glycation end-products [substudy] Generation of oxidative species [substudy] Lipids in various fractions [substudy] Retinyl ester measurements in various fractions [substudy] Composition of triglyceride-rich lipoproteins [substudy] Compartmental modeling of postprandial lipemia [substudy] Apolipoproteins [substudy]
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Have type 2 diabetes (World Health Organization [WHO] classification
- Have used one or more of the following oral anti-hyperglycemic medications-metformin
or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide,
gliclazide, glimepiride) alone or in combination with one or two insulin injections
per day for at least 3 months immediately prior to entering the study. Patients using
more than 2 insulin injections per day or subcutaneous insulin infusion prior to the
study will not be eligible to participate.
- Have a hemoglobin A1c between 6. 5% and 11%, inclusive, according to the central
laboratory at Visit 1.
- Have clinically acceptable LDL-C, in the investigator's opinion, at Visit 1.
- As determined by the investigator, are capable and willing to learn how to use the
insulin injection pens; comply with their prescribed diet, exercise, and medication
regimen; perform self-monitoring of blood glucose; and use the patient diary as
required for this protocol.
Exclusion Criteria:
- Have hypersensitivity to metformin or a known allergy to metformin hydrochloride,
insulin lispro MM, insulin lispro LM, or insulin glargine, or excipients contained in
these products.
- Have known metabolic or lactic acidosis.
- Have a history of renal transplantation or are currently receiving renal dialysis or
have serum creatinine greater than or equal to 135 micromol/L (1. 5 mg/dL) for males
and greater than or equal to 110 micromol/L (1. 2 mg/dL) for females.
- Have cardiac disease with functional status that is Class III or IV
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,
or alanine transaminase (ALT) greater than three times the upper limit of the
reference range as defined by the central laboratory.
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Thessaloniki 56429, Greece
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Den Helder 1783 GZ, Netherlands
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Olesnica 56-400, Poland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ponce 00731, Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mumbai, Maharstra 400 007, India
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lebanon, New Hampshire 03756, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., St Leonards, New South Wales 2065, Australia
Additional Information
Starting date: December 2003
Ending date: September 2005
Last updated: July 28, 2006
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