Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®
Completed
Novo Nordisk A/S
2007-11-01
This trial is conducted in Europe. The aim of this observational study is to evaluate the
change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal
clinical practice conditions.
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
Completed
Novo Nordisk A/S
2007-10-01
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON
INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when
using Levemir® versus Protaphane® in combination with OADs in daily settings.
Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
Completed
Sanofi
Phase 4
2010-07-01
Primary Objective:
>To obtain an estimation for both treatment groups of the proportion of patients that reach
the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.
Secondary Objectives:
- Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and
after each period of treatment.
- Incidence of confirmed symptomatic and nocturnal hypoglycemia.
- Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover).
>Weight variation for each period of treatment.
- Creatinine clearance at baseline and after each period of treatment.
- Overall safety: Incidence of adverse events.
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