Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00191464
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HbA1C
- Secondary Outcome Measures
Name Time Method Total cholesterol Oxidized LDL Fibrinogen Frequency and incidence of hypoglycemia Surrogate measure of vascular reactivity [substudy] Inflammatory markers [substudy] Production of advanced glycation end-products [substudy] Retinyl ester measurements in various fractions [substudy] Triglycerides Pilot two questionnaires for microvascular complications Apolipoproteins [substudy] Lipids in various fractions [substudy] High-density lipoprotein cholesterol Composition of triglyceride-rich lipoproteins [substudy] General inflammation (hsCRP) Lipoproteins and apoproteins Generation of oxidative species [substudy] Compartmental modeling of postprandial lipemia [substudy] Blood glucose levels (based on self-monitoring) Insulin dose Safety General well-being Coagulopathy factors [substudy] Estimates of low-density lipoprotein cholesterol Nuclear magnetic resonance [NMR] analysis of lipids Weight
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 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇵🇷Ponce, Puerto Rico