Status:
COMPLETED
Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes
Lead Sponsor:
University of Florida
Collaborating Sponsors:
VA Office of Research and Development
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (NAFLD) has not been systematically studied before, and in particular, never when using the new ...
Detailed Description
The control of hyperglycemia in T2DM ameliorates the metabolic abnormalities of T2DM but whether this improves hepatic steatosis has not been examined carefully with the use of improved insulin formul...
Eligibility Criteria
Inclusion
- To participate patients must:
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
- Age range of 18 to 70 years (inclusive).
- Patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period.
- All participants must have the following laboratory values:
- Hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
- Serum creatinine ≤ 1.5 mg/dl
- AST (SGOT) ≤ 2.5 times upper limit of normal
- ALT (SGPT) ≤ 2.5 times upper limit of normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal
Exclusion
- Patients will be excluded if any of the following criteria are present:
- Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl.
- Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 2 months prior to study entry.
- Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded.
- Past (within 1 year) or current history of alcohol abuse.
- Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00998335
Start Date
June 1 2007
End Date
February 1 2010
Last Update
September 28 2016
Active Locations (1)
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1
The University of Texas H.S.C. at San Antonio and the San Antonio Audie L. Murphy VA Hospital
San Antonio, Texas, United States, 78229-3900