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
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Indonesia | Novo Nordisk Investigational Site | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Indonesia,
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 |
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