Phase 4
Completed N=296
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00537303 ↗Enrolled (actual)
296
Serious AEs
4.1%
Results posted
Aug 2010
Primary outcomePrimary: Glycosylated Haemoglobin A1c (HbA1c) — 7.67; 7.61 percentage (%) of total haemoglobin — p=0.606
Summary
This trial is conducted in Europe, Africa and the United States of America (USA).
The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
7.55; 7.52 | 0.816 |
| PRIMARY Glycosylated Haemoglobin A1c (HbA1c) |
7.55; 7.52 | 0.816 |
| SECONDARY Hypoglycaemic Episodes |
1; 4; 531; 567; 283; 344 | — |
| SECONDARY Biochemistry: Serum Alanine Aminotransferase |
30.09; 27.04 | — |
| SECONDARY Haematology: Haemoglobin Measured in Blood |
8.57; 8.58 | — |
| SECONDARY Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide |
3.76; 4.67 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus for more than 6 months
- HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
- BMI (Body Mass Index) less than 40 kg/m2
- Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
- Treatment with one to 3 OADs
Exclusion Criteria
- Known or suspected allergy to trial products or related products
- Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
- Previous participation in any trial including this for the last 6 months
- Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)
Data sourced from ClinicalTrials.gov (NCT00537303). 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.