Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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