| Trial ID: | L2516 |
| Source ID: | NCT00715780
|
| Associated Drug: |
Soluble Human Insulin
|
| Title: |
Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| 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
|
| Outcome Measures: |
Primary: Incidence of major hypoglycaemic episodes, during 26 weeks of insulin therapy | Secondary: 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|Change in FPG 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|Weight change, at the end of the study|Percentage of patients reaching the target of HbA1c less than 7.5%, at the end of the study|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
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1667
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2008-06
|
| Completion Date: |
2009-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-11-06
|
| Locations: |
Novo Nordisk Investigational Site, Jakarta, 12520, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT00715780
|
