Phase 4
Completed N=161
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs
Source: ClinicalTrials.gov NCT00537277 ↗Enrolled (actual)
161
Serious AEs
3.1%
Results posted
Aug 2010
Primary outcomePrimary: Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% — 34.4; 46.9 percentage of subjects
Summary
This trial is conducted in Europe.
This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% |
34.4; 46.9 | — |
| SECONDARY Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% |
48.2; 51.8 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
4; 43; 15 | — |
| SECONDARY Number of Diurnal Hypoglycaemic Episodes |
2; 33; 13 | — |
| SECONDARY Number of Nocturnal Hypoglycaemic Episodes |
2; 10; 2 | — |
| SECONDARY Number of Treatment Emergent Serious Adverse Events (SAEs) |
7 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes Mellitus for more than 12 months
- HbA1c: 7.5 - 11.0%
- An antidiabetic regimen that has been stable for at least 3 months prior to screening
- An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
- OADs dosed at 50% or more of the maximum recommended dose
Exclusion Criteria
- Use of any insulin preparations other than NPH or glargine within the past 6 months
- Use of more than 60 units of insulin per day
- Morning time insulin administration
- Use of more than one insulin dose daily
Data sourced from ClinicalTrials.gov (NCT00537277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.