Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

Summary

Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary Objective: To compare between treatment groups: * Plasma glucose (fasting, nocturnal) over time, * Changes from baseline in HbA1c over time, * Percentage of patients who reach the target of HbA1c \<7 and \<6.5, * Use of prandial insulin as rescue medication at month 6, * Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), * Daily dose of insulin, * Change in body weight from baseline, * Evolution of 8-point plasma-glucose (PG) profiles, * Overall safety, * Patient reported outcomes (treatment satisfaction).

Timeline

Start

2009-07

Primary completion

2012-07

Completion

2012-07

Publications

• Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
• Home PD, Bolli GB, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain MP, Riddle MC. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naive people with type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.

Drugs

Indications