Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-Diabetic Agents - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00715780

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: soluble human insulin Drug: biphasic human insulin Drug: insulin NPH Drug: insulin aspart Drug: biphasic insulin aspart Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-Diabetic Agents

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of major hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Frequency and type of hypoglycaemic episodes [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
Frequency and type of adverse events [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
Frequency and type of adverse drug reactions [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: Yes ]
Change in HbA1c from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
Change in PPG from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
Change in FPG from baseline [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
Subjects' insulin treatment satisfaction [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
Physicians' satisfaction with insulin therapy [ Time Frame: during 26 weeks of insulin therapy ] [ Designated as safety issue: No ]
Weight change [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Percentage of patients reaching the target of HbA1c less than 7.5% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Percentage of patients reaching the target of HbA1c less than 7% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Percentage of patients reaching the target of HbA1c less than 6.5% [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: soluble human insulin Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation Drug: biphasic human insulin Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation Drug: insulin NPH Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation Drug: insulin aspart Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation Drug: biphasic insulin aspart Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation Drug: insulin detemir Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Groups/Cohorts

Assigned Interventions

A

Drug: soluble human insulin