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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: soluble human insulin; Drug: biphasic human insulin; Drug: insulin NPH; Drug: insulin aspart; Drug: biphasic insulin aspart; Drug: insulin detemir

• Registration Number: NCT00715780
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1667

Inclusion Criteria

• Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
• Insulin naive
• Poor glycaemic control on OADs and decided by the physician to start insulin therapy

Exclusion Criteria

• Type 1 diabetes patients
• Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Patients with a hypersensitivity to insulin or to any of the excipients
• Patient groups not approved in the product label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic human insulin	-
A	soluble human insulin	-
A	insulin NPH	-
A	biphasic insulin aspart	-
A	insulin detemir	-
A	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Incidence of major hypoglycaemic episodes	during 26 weeks of insulin therapy

Secondary Outcome Measures

Name	Time	Method
Frequency and type of adverse drug reactions	during 26 weeks of insulin therapy
Change in HbA1c from baseline	during 26 weeks of insulin therapy
Change in PPG from baseline	during 26 weeks of insulin therapy
Subjects' insulin treatment satisfaction	during 26 weeks of insulin therapy
Physicians' satisfaction with insulin therapy	during 26 weeks of insulin therapy
Percentage of patients reaching the target of HbA1c less than 7%	at the end of the study
Percentage of patients reaching the target of HbA1c less than 6.5%	at the end of the study
Weight change	at the end of the study
Change in FPG from baseline	during 26 weeks of insulin therapy
Percentage of patients reaching the target of HbA1c less than 7.5%	at the end of the study
Frequency and type of hypoglycaemic episodes	during 26 weeks of insulin therapy
Frequency and type of adverse events	during 26 weeks of insulin therapy

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇩 Jakarta, Indonesia