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

• Status: Completed
• Trial end date: 2012-07-01

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).

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Glycoside Hydrolase Inhibitors; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Globin Zinc