Phase 4
Completed N=87
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Source: ClinicalTrials.gov NCT00455858 ↗Enrolled (actual)
87
Serious AEs
5.8%
Results posted
Feb 2010
Primary outcomePrimary: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 — 9.3; 8.2; -1.2 percentage change in HbA1c — p=<.0001
Summary
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 |
9.3; 8.2; -1.2 | <.0001 sig |
| SECONDARY Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 |
9.3; 8.2; -1.2 | <.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
178; 118; 116; -60; -62 | <.0001 sig |
| SECONDARY Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% |
14.6; 85.4; 12.3; 87.7 | — |
| SECONDARY Occurence of Hypoglycaemic Episodes |
92; 78; 170 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed more than 12 months ago)
- HbA1c greater than 7.0 and less than 12.0% at screening
- Currently on any OAD in more than 3 months ago
- BMI (Body Mass Index) less than 35kg/m2
Exclusion Criteria
- Previous treatment with insulin in more than 7 days within the last 3 months
- Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
Data sourced from ClinicalTrials.gov (NCT00455858). 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.