Phase 3
Completed N=708
Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00184600 ↗Enrolled (actual)
708
Serious AEs
37.0%
Results posted
Jul 2011
Primary outcomePrimary: HbA1c (Glycosylated Haemoglobin) at Month 12 — 8.45; 8.55; 8.63; 7.64 percentage (%) of total haemoglobin
Summary
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (Glycosylated Haemoglobin) at Month 12 |
8.45; 8.55; 8.63; 7.64; 7.20; 7.33 | — |
| PRIMARY HbA1c (Glycosylated Haemoglobin) at Month 36 |
8.45; 8.55; 8.63; 7.11; 7.04; 7.22 | — |
| SECONDARY Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5% |
8.1; 23.9; 17.0; 78.9; 43.9; 52.5 | — |
| SECONDARY Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5% |
43.2; 44.8; 31.9 | — |
| SECONDARY Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5% |
2.0; 8.0; 5.0; 0; 8.0; 3.9 | — |
| SECONDARY Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5% |
2.7; 5.7; 3.8; 1.7; 5.5; 3.0 | — |
| SECONDARY Percentage of Participants Who Required A Second Insulin Therapy by Month 12 |
17.9; 4.2; 8.9 | — |
| SECONDARY Percentage of Participants Who Required A Second Insulin Therapy by Month 36 |
89; 82; 88 | — |
| SECONDARY Change From Baseline in Body Weight at Month 12 |
1.9; 5.7; 4.7 | — |
| SECONDARY Change From Baseline in Body Weight at Month 36 |
3.6; 6.4; 5.7 | — |
| SECONDARY Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 12 Months |
-43; -65; -59; -59; -23; -45 | — |
| SECONDARY Change in Eight-point Capillary Plasma Glucose Profiles (Self-measured) at 36 Months |
-58; -67; -56; -47; -49; -50 | — |
| SECONDARY Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 12 Months |
0.78; 0.76; 0.76 | — |
| SECONDARY Quality of Life as Measured by the EuroQol Group 5-Dimension Self-Report Questionnaire Score (EQ5D) at 36 Months |
0.80; 0.77; 0.76 | — |
| SECONDARY Number of Participants Having an 'Other' Adverse Event |
227; 235; 228 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Insulin naive
- On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
- HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)
Exclusion Criteria
- Proliferative retinopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Data sourced from ClinicalTrials.gov (NCT00184600). 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.