Clinical trial NCT00715780: Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 1667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of major hypoglycaemic episodes
timeFrame: during 26 weeks of insulin therapy
Secondary outcomes:
measure: Frequency and type of hypoglycaemic episodes
timeFrame: during 26 weeks of insulin therapy
measure: Frequency and type of adverse events
timeFrame: during 26 weeks of insulin therapy
measure: Frequency and type of adverse drug reactions
timeFrame: during 26 weeks of insulin therapy
measure: Change in HbA1c from baseline
timeFrame: during 26 weeks of insulin therapy
measure: Change in PPG from baseline
timeFrame: during 26 weeks of insulin therapy
measure: Change in FPG from baseline
timeFrame: during 26 weeks of insulin therapy
measure: Subjects' insulin treatment satisfaction
timeFrame: during 26 weeks of insulin therapy
measure: Physicians' satisfaction with insulin therapy
timeFrame: during 26 weeks of insulin therapy
measure: Weight change
timeFrame: at the end of the study
measure: Percentage of patients reaching the target of HbA1c less than 7.5%
timeFrame: at the end of the study
measure: Percentage of patients reaching the target of HbA1c less than 7%
timeFrame: at the end of the study
measure: Percentage of patients reaching the target of HbA1c less than 6.5%
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: