A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients with Type 2 Diabetes Mellitus: Two Populations with Different I...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005381-37

A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients with Type 2 Diabetes Mellitus: Two Populations with Different Insulin Treatment Options

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Extrait

The primary objectives are to test the hypothesis that: For insulin-naïve patients whose type 2 diabetes is not optimally controlled by 2 or more oral antihyperglycemic medications (including patients who are taking only one oral agent but are considered to be appropriate candidates for insulin therapy), patients whose diabetes care options include Human Insulin Inhalation Powder (HIIP) (“standard options + HIIP”), as compared with patients whose options do not include HIIP (“standard options”), will achieve: • Superior acceptance of insulin therapy, as measured by the proportion of patients in each group who are using insulin at study endpoint. • Noninferior glycemic control, as measured by mean change in HbA1c from baseline to study endpoint, with noninferiority margin of 0.3%. • Superior glycemic control, as measured by mean change in HbA1c from baseline to study endpoint.


Critère d'inclusion

  • Male or female non smoking adults (18-100 years old), diagnosed type 2 Diabetes Mellitus for at least 6 months duration at study entry. Taking at least one or more oral anti-hyperglycemic medication and are insulin-naïve. They should have HbA1c between 7.5 and 11.0

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