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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715780
• Other study ID #: INS-3615
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: November 4, 2016
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: November 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1667
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• soluble human insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic human insulin
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• insulin NPH
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
Indonesia	Novo Nordisk Investigational Site	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major hypoglycaemic episodes		during 26 weeks of insulin therapy	Yes
Secondary	Frequency and type of hypoglycaemic episodes		during 26 weeks of insulin therapy	Yes
Secondary	Frequency and type of adverse events		during 26 weeks of insulin therapy	Yes
Secondary	Frequency and type of adverse drug reactions		during 26 weeks of insulin therapy	Yes
Secondary	Change in HbA1c from baseline		during 26 weeks of insulin therapy	No
Secondary	Change in PPG from baseline		during 26 weeks of insulin therapy	No
Secondary	Change in FPG from baseline		during 26 weeks of insulin therapy	No
Secondary	Subjects' insulin treatment satisfaction		during 26 weeks of insulin therapy	No
Secondary	Physicians' satisfaction with insulin therapy		during 26 weeks of insulin therapy	No
Secondary	Weight change		at the end of the study	No
Secondary	Percentage of patients reaching the target of HbA1c less than 7.5%		at the end of the study	No
Secondary	Percentage of patients reaching the target of HbA1c less than 7%		at the end of the study	No
Secondary	Percentage of patients reaching the target of HbA1c less than 6.5%		at the end of the study	No

External Links

•   Clinical Trials at Novo Nordisk