Phase 4
Completed N=179
Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756
Source: ClinicalTrials.gov NCT01278160 ↗Enrolled (actual)
179
Serious AEs
1.7%
Results posted
Oct 2012
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline — -0.13; -0.12 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline |
-0.13; -0.12 | — |
| SECONDARY 9-point SMPG (Self Measured Plasma Glucose) Profile |
6.02; 6.23; 8.56; 8.61; 6.42; 6.79 | 0.2569 |
| SECONDARY Percentage of Subjects Achieving HbA1c Below 7.0% |
12.4; 14.4 | 0.7312 |
| SECONDARY Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% |
2.2; 7.8 | 0.1257 |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes |
108; 143; 18; 11; 84; 127 | 0.1911 |
Eligibility Criteria
Inclusion Criteria
- Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
- HbA1c above or equal to 7.0%
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
Exclusion Criteria
- Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
- Known proliferative retinopathy or maculopathy requiring acute treatment
- Any disease or condition which the Investigator (trial physician) feels would interfere with the trial
Data sourced from ClinicalTrials.gov (NCT01278160). 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.