NCT00715780CompletedNot Applicable
Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 1,667
- Locations
- 1
- Primary Endpoint
- Incidence of major hypoglycaemic episodes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Intervention: insulin NPH (Drug)
A
Intervention: insulin aspart (Drug)
A
Intervention: biphasic human insulin (Drug)
A
Intervention: soluble human insulin (Drug)
A
Intervention: biphasic insulin aspart (Drug)
A
Intervention: insulin detemir (Drug)
Outcomes
Primary Outcomes
Incidence of major hypoglycaemic episodes
Time Frame: during 26 weeks of insulin therapy
Secondary Outcomes
- Frequency and type of hypoglycaemic episodes(during 26 weeks of insulin therapy)
- Frequency and type of adverse events(during 26 weeks of insulin therapy)
- 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)
Investigators
Study Sites (1)
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