EPG Diabetes Knowledge Centre
Effective in combination therapy
NovoNorm® is highly effective in combination therapy
The ability of NovoNorm® as part of a combination regimen to improve glycaemic control in patients with poorly controlled type 2 diabetes has been demonstrated in studies involving, respectively, metformin21, rosiglitazone22 and pioglitazone23 as well as NPH insulin24. In addition, the profile of combination therapy in an every day clinical setting has been demonstrated in a large-scale assessment of NovoNorm®-based combination therapy17.
NovoNorm®-metformin combination
In a three-month study of 83 patients with type 2 diabetes no longer adequately controlled by metformin, the addition of NovoNorm® resulted in significant improvements in glycaemic control, compared to the groups who received one of those treatments21. HbA1C decreased from 8.3 to 6.9% (p = 0.0016), and fasting plasma glucose decreased from 10.22 to 8.04 mmol/l (p = 0.0003) with combination therapy. 59% of these patients achieved optimal glycaemic control (HbA 1C < 7.1%). No severe hypoglycaemic events were reported in association with the combination.
The addition of NovoNorm® to metformin in patients no longer adequately controlled by metformin monotherapy resulted in a significant improvement (p < 0.002) in glycaemic control. The Figure shows the change in HbA
NovoNorm®-glitazone combination
Two comparison studies of monotherapy and combination therapy of NovoNorm® with rosiglitazone and pioglitazone, respectively, have been realised.22,23 In both studies, HbA1C decreased more significantly in the group receiving the combination regimen, compared to the two groups receiving a monotherapy of either NovoNorm® or a glitazone.
NovoNorm® is indicated for combination use with pioglitazone or rosiglitazone in the USA, but not yet in Europe.
NovoNorm® bedtime NPH insulin combination
Clinical trial data show that the combination of NovoNorm® with bedtime NPH insulin is a suitable strategy for achieving blood glucose control objectives in patients with type 2 diabetes who were previously inadequately controlled when treated with sulphonylureas with or without metformin.24 In a study of 56 such patients, the combination of NovoNorm® with bedtime NPH insulin was associated with a significantly greater improvement in glycaemic control after 14 weeks than was achieved by either agent alone. HbA1C decreased by 1.68 and 1.9 percentage points in patients receiving the combination regimen relative to patients receiving monotherapy with NPH insulin or NovoNorm®, respectively. Fasting plasma glucose also decreased to a significantly greater extent over the study period with combination therapy (–5.43 mmol/l) than with monotherapy (insulin monotherapy, –2.23 mmol/l; NovoNorm®monotherapy, +0.16 mmol/l). Despite the significant improvement in control associated with the NovoNorm®-NPH combination, there were no reports of severe hypoglycaemia in patients receiving this treatment.
NovoNorm® is not yet indicated for combination use with insulin.
The combination of NovoNorm® and NPH insulin resulted in significant improvement in glycaemic control (p < 0.01) in patients with Type 2 diabetes no longer controlled by sulphonylurea ±metformin. The Figure shows the mean change in HbA1C over the study period with either NPH insulin, NovoNorm® or the combination of these agents.24