Phase 3
Completed N=441
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00627445 ↗Enrolled (actual)
441
Serious AEs
3.2%
Results posted
Mar 2010
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) — -1.790; -1.517 percentage (%) of total haemoglobin
Summary
This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) |
-1.790; -1.517 | — |
| SECONDARY The Percentage of Subjects Achieving HbA1c Treatment Targets |
65; 52; 47; 29 | — |
| SECONDARY Change and Daily Average in 8-point Plasma Glucose |
-2.52; -2.43; -3.92; -4.00; -2.80; -2.71 | — |
| SECONDARY Change and Daily Average in Prandial Plasma Glucose Increment |
-1.41; -1.58; -1.57; -0.44; 0.40; -0.53 | — |
| SECONDARY The Total Increase in Total Daily Insulin Dose Per Body Weight |
0.963; 0.820 | — |
| SECONDARY Change in Body Weight |
1.188; 0.817 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
728; 679; 158; 198; 157; 198 | — |
| SECONDARY Number of Nocturnal Hypoglycaemic Episodes |
134; 81; 31; 30; 31; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
- HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
- FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
- BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)
Exclusion Criteria
- Metformin contraindications according to local practice
- Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial
Data sourced from ClinicalTrials.gov (NCT00627445). 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.