Status:
COMPLETED
Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Type 2 Diabetes Mellitus
Hypoglycemia
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, suc...
Detailed Description
Patients were randomized to either NPL (Lilly) or glargine (Lantus, Aventis) to be administered subcutaneously at bedtime. Both insulin formulations consisted of cartridge containing 3 ML of either in...
Eligibility Criteria
Inclusion
- Men and women aged 30-70 years, with a duration of known diabetes \> 2 years
- And treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
- Body mass index less than 40 kg/m2
- HbA1c level between 7.5 and 10%
- And fasting plasma glucose of 120 mg/dL or greater.
Exclusion
- Exclusion criteria included pregnancy or breast-feeding
- Previous use of insulin or other antihyperglycemic drugs
- Investigational drug within the previous 3 months
- Use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
- Presence of any clinically relevant somatic or mental diseases
- To minimize the likelihood of including subjects with late-onset type 1 diabetes
- Candidate with a positive test for anti-GAD antibody or with fasting plasma C-peptide less than 0.25 pmol/ml were excluded
- Also excluded were patients with abnormal safety laboratory tests
- Including liver enzymes (ALT, AST, AFOS) higher than three times the upper limit of normal and serum creatinine \> 1.4 mg/dL)
- History of drug abuse
- Poor compliance with the 8-point daily glucose profile measurement
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00641407
Start Date
January 1 2007
End Date
March 1 2008
Last Update
March 31 2008
Active Locations (1)
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1
Department of Geriatrics and Metabolic Disease
Naples, Italy, 80138