Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal.

The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment.

This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second University of Naples; University of Campania "Luigi Vanvitelli"
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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