Phase 4
Completed N=293
Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Source: ClinicalTrials.gov NCT00669864 ↗Enrolled (actual)
293
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Change in HbA1c (Glycosylated Haemoglobin A1c) — -1.303 percentage (%) of total haemoglobin — p=<0.0001
Summary
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Glycosylated Haemoglobin A1c) |
-1.303 | <0.0001 sig |
| SECONDARY Change in 8-point Plasma Glucose Profile |
-1.95; -3.69; -2.60; -2.67; -2.38; -3.63 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Less Than 7.0% |
60.4 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% |
38.9 | — |
| SECONDARY Hypoglycaemic Episodes |
0; 39; 203 | — |
| SECONDARY Hypoglycaemic Episodes, Diurnal/Nocturnal |
188; 34; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
- HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
- BMI (Body Mass Index) maximum 40 kg/m2
Exclusion Criteria
- Metformin contraindications according to local practice
- Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial
Data sourced from ClinicalTrials.gov (NCT00669864). 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.