Phase 4
Completed N=480
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00469092 ↗Enrolled (actual)
480
Serious AEs
4.9%
Results posted
Jan 2010
Primary outcomePrimary: Glycosylated Haemoglobin A1c (HbA1c) — 7.08; 7.23 percentage of total haemoglobin — p=0.029
Summary
This trial is conducted in Africa, Asia, Europe, Oceania and South America.
This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
7.08; 7.23 | 0.029 sig |
| SECONDARY 9-point Self-measured Plasma Glucose Profiles |
6.73; 6.56; 9.40; 9.07; 7.24; 7.28 | 0.0059 sig |
| SECONDARY Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) |
54; 60; 101; 106; 134; 132 | — |
| SECONDARY Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) |
83.10; 83.06; 73.25; 73.47; 72.42; 72.81 | — |
| SECONDARY Number of Hypoglycaemic Episodes |
443; 318; 265; 224; 3; 3 | — |
| SECONDARY Number of Subjects Reporting Treatment Emergent Adverse Events |
117; 115 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
- Ongoing stable treatment with metformin for at least 2 months
- Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
- Insulin naive
- HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)
Exclusion Criteria
- Metformin contraindication according to local practice
- TZD (thiazolidinedione) treatment for the last 5 months before trial start
- Systemic treatment with any corticosteroid 3 months before trial start
- Any disease or condition which according to the Investigator would interfere with the trial
Data sourced from ClinicalTrials.gov (NCT00469092). 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.