The INITIATE study: NovoMix® 30 shows improved blood glucose control compared with insulin glargine

(February 2005)

NovoMix® 30, a premix insulin analogue, is more effective than insulin glargine in helping people with type 2 diabetes, who are new to insulin therapy, achieve targeted HbA1C levels, according to a study published today in the February issue of Diabetes Care. * A total of 66% of patients using NovoMix® 30 reached target HbA1C levels, compared with only 40% receiving insulin glargine.

“This study demonstrates the value of initiating insulin therapy with a dual-acting insulin analogue, particularly in patients with HbA1C values greater than 8.5%,” said the study’s lead investigator Philip Raskin, MD, Professor of Medicine, University of Texas Southwestern Medical Center, Dallas. Equally important is that clinicians may now want to think about earlier insulin initiation as INITIATE shows that starting insulin treatment in type 2 diabetes is safe and relatively easy.”

NovoMix® 30 – a premix analogue
NovoMix® 30 is a premix insulin analogue containing a rapid-acting component (insulin aspart) to tackle mealtime glucose excursions, and a slow-release insulin (protaminated insulin aspart) for basal control. This dual release combination offers a convenient and flexible treatment option that addresses both mealtime and fasting plasma glucose and requires only one injection twice a day. Indeed, NovoMix® 30 is widely used in patients with type 2 diabetes starting insulin treatment for the first time as it offers good glycaemic control and fewer daily injections than other insulin regimens.

INITIATE:  Improved Blood Glucose Control
INITIATE evaluated 233 insulin-naïve patients whose blood glucose levels were not adequately controlled with oral diabetes medications (HbA1C levels ≥ 8%).  At the end of the 28-week open-label, parallel-group study, not only did more patients taking NovoMix® 30 reach the American Diabetes Association HbA1C target of less than 7.0 percent (compared with 40 percent taking insulin glargine), but the average HbA1C value in the NovoMix® 30 group was significantly lower than in the insulin glargine group (6.9 percent versus 7.4 percent, p<0.01). Both study arms received metformin, an oral diabetes medication, and approximately 10% of patients received pioglitazone.

Patients taking NovoMix® 30 also demonstrated significantly less of a rise in post-mealtime glucose levels compared with insulin glargine at breakfast and dinner. Overall post-prandial glycaemic (PPG) exposure was approximately 25 percent less for the NovoMix® 30 group than for the insulin glargine group.

Research shows that managing post-mealtime levels of glucose accounts for as much as 70 percent of total glycaemic control in patients with HbA1C values less than 7.3 percent, and for about 50 percent in patients with HbA1C values between 7.3 percent and 8.4 percent.

“Given the importance of post-meal blood glucose control in overall diabetes management, the study suggests that patients treated with NovoMix® 30 have an advantage in getting to the recommended HbA1C targets compared to those treated with a basal-only insulin,” said Dr Raskin.  “Therefore, NovoMix® 30 may be a reasonable treatment option for type 2 diabetes patients initiating insulin therapy.” 


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