International Journal of Clinical Practice
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Improved glycaemic control and treatment satisfaction in largest ever database of patients with type 2 diabetes: The IMPROVE™ study

Initiating with or switching insulin therapy to biphasic insulin aspart 30/70 (NovoMix® 30) in routine care results in improved glycaemic control, reduced major hypoglycaemia, and greater treatment satisfaction.

These are the results of the IMPROVE™ observational study, published in the March 2009 issue of the International Journal of Clinical Practice [1]. The results are for approximately 52,000 patients with type 2 diabetes, in countries across three continents.

There were three sub-groups of patients.  Some had received no prior pharmaceutical therapy. Others had received oral anti-diabetic therapy only. A third group had had insulin (basal, prandial, basal-bolus or premixed), sometimes with oral anti-diabetic therapy.

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During the study, every sub-group improved their blood sugar levels. Those who had received no prior pharmaceutical therapy experienced the most significant reduction in blood sugar expressed as HbA1c (3.1%), while those who were poorly controlled on oral anti-diabetic drugs and/or insulin therapy experienced reductions of 2.1% and 2.0% respectively.  Overall, 53% of the patients in the study achieved an HbA1c of less than 7%, the International Diabetes Federation target. 

The study showed the importance of starting insulin therapy early in type 2 patients.

“This is one of the most important messages – not to wait too long before starting insulin,” said lead author Paul Valensi, Professor of Nutrition and diabetologist at the Jean Verdier Hospital at Paris-Nord University.

Average HbA1c levels were 9.4% at the beginning of the study. As a result, many patients had macro- and microvascular complications when they were enrolled.

“After a few months or a very few years, we have to consider starting on insulin…  We know from important controlled trials performed on types 1 and 2 patients that tightly controlling glycaemic parameters is able to prevent micro- and also macrovascular complications. So we have to offer this opportunity to all of our patients, and in many cases, that consists of insulin therapy,” said Valensi.

The study also presented data specific to the participating countries in Europe, Asia and the Gulf, and Canada. There were some differences in baseline therapy and patients, but the benefits of biphasic insulin aspart 30/70 were observed across all countries.

All patients expressed improved satisfaction with their treatment.  A study effect cannot be discounted, said Professor Valensi: “We may not exclude psychological inference on the results….But I don’t think the study effects are important, and as the results have been confirmed over such a huge number of patients, I think they’re reliable.”

The IMPROVE™ study has other data to analyse. One paper, in press, is about the sub-group of patients who were previously on biphasic human insulin and who switched to biphasic insulin aspart 30/70 during the study.  In these patients, blood sugar expressed as HbA1c decreased by about 2%.  This resulted from a decrease in fasting and post prandial glucose.  These patients also had fewer major hypoglycaemic events. 

The data in press also consider how best to make the switch from other insulin to biphasic insulin aspart 30/70. “The best result in terms of HbA1c,” said Valensi, “was in the sub-group of patients who made a unit-for-unit switch.” 

Wendy Barnaby, Journalist and broadcaster


1. Valensi P, Benroubi M, Borzi B et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study. Int J Clin Pract 2009;63(3):522-31.

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Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study.
Valensi P, Benroubi M, Borzi B et al. Int J Clin Pract 2009;63(3):522-31

Aims: The IMPROVE™ observational study evaluated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in patients with type 2 diabetes in routine practice in 11 countries.

Methods: Patients who initiated insulin therapy with, or switched existing insulin therapy to, BIAsp 30 in routine care were eligible for this 26-week, non-interventional observational study. Data on adverse events, hypoglycaemia and glycaemic parameters were obtained from patients' diaries and medical notes. Questionnaire-based patient treatment satisfaction was also measured. We report global results and, uniquely for a diabetes observational study, country-specific data.

Results: A total of 52,419 patients were enrolled from three prestudy treatment groups: no pharmaceutical therapy (n = 8966, diabetes duration 2.0 years, baseline HbA1c 9.9%), oral antidiabetic drugs (OADs) only (n = 33,797, diabetes duration 7.4 years, baseline HbA1c 9.2%) and insulin ± OADs (n = 9568, diabetes duration 10.4 years, baseline HbA1c 9.3%). At final visit, HbA1c, fasting and postprandial blood glucose were significantly reduced from baseline in all subgroups (no pharmaceutical therapy: −3.1%, −5.9 and −9.0 mmol/l, respectively; OADs-only: −2.1%, −4.1 and −6.1 mmol/l; insulin ± OADs: −2.0%, −3.3 and −5.1 mmol/l). Major hypoglycaemia rates decreased in all subgroups; minor hypoglycaemia increased in the insulin-naïve groups. There was no mean weight gain across subgroups. Across all countries, glycaemic parameters and major hypoglycaemia were reduced; weight increases were seen in some countries. Treatment satisfaction increased in all subgroups and countries following BIAsp 30 therapy.

Conclusions: Initiating insulin with, or switching insulin therapy to, BIAsp 30 in routine care resulted in improved glycaemic control, reduced major hypoglycaemia and greater treatment satisfaction.

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Video Interview with Professor Paul Valensi

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Author Profile

Professor Paul Valensi

Professor Valensi heads the department of Endocrinology, Diabetology and Nutrition at Jean Verdier Hospital in Bondy, France and is Director of the Laboratory of Nutrition, Metabolic Diseases & Cardiovascular Prevention at Paris-Nord University.

Professor Valensi is a member of the Executive Committee of Diabetes and Cardiovascular Disease EASD Study Group, and his research interests encompass macro and microvascular complications of diabetes and obesity, neuropathic disorders in diabetes and obesity, and the prevention of diabetes and its complications. He has published around 220 peer reviewed articles, 30 book chapters, and has contributed to multiple clinical guidelines both in diabetes and cardiovascular risk management.