Issue 164 Item 7 Glargine Vs. NPH In Combo With Oral Treatment In Type 2’s

Glargine showed fewer episodes of nocturnal hypoglycemia.

A European, randomized, 29-center, open-label study compared the safety and efficacy of two formulations of insulin glargine and neutral protamine Hagedorn (NPH) human insulin, in combination with oral agents, in patients with Type 2 diabetes mellitus (DM).

Two-hundred-and-four patients with Type 2 DM, in whom oral treatment alone was inadequate, were randomized to insulin glargine with 30 micro g/ml zinc [insulin glargine (30)], or insulin glargine with 80 micro g/ml zinc [insulin glargine (80)] or NPH insulin subcutaneously once daily. Insulin was titrated to aim for fasting blood glucose (FBG) values between 4 and 7 mmol/l.

All participants received oral therapy during the 3-week titration phase and 1-week maintenance phase of the trial. RESULTS: No differences between treatment groups were observed in adjusted mean fasting plasma glucose; significant decreases of 3.4 mmol/l, 3.5 mmol/l and 3.1 mmol/l were observed within the insulin glargine (30), insulin glargine (80) and NPH insulin groups, respectively (P < 0.0001 in each case).  

No differences between groups, but significant changes within groups, were observed in self-monitored FBG, mean FBG, blood glucose profile, stability of FBG, nocturnal blood glucose, fasting serum C-peptide, non-esterified fatty acids, hemoglobin A1c, fructosamine and fasting serum insulin.

A significantly greater proportion of NPH insulin patients experienced symptomatic nocturnal hypoglycemia (19.1 NPH group vs. 7.3% glargine groups; P = 0.0123). Both insulins were well tolerated; one patient in each group experienced an injection site reaction.

From the results it was concluded that insulin glargine is as safe and effective as NPH insulin given once daily and in this study caused fewer episodes of nocturnal hypoglycemia. Diabet. Med. 20, 545-551 (2003)

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