|By Marketwired .||
|July 2, 2014 08:01 PM EDT||
BRAMPTON, ON--(Marketwired - July 02, 2014) - As an example of its commitment to improving clinical outcomes for all people with diabetes, Medtronic, Inc. (NYSE: MDT) today announced the results of the global OpT2mise trial, which included eight participating centres in Canada. The results showed that MiniMed insulin pumps safely achieve better glucose control for people with insulin-requiring type 2 diabetes than multiple daily injections. While the benefits of continuous subcutaneous insulin infusion (CSII) with an insulin pump for people with type 1 diabetes are well proven, this is the largest global study to evaluate the comparative efficacy of CSII with an insulin pump versus multiple daily insulin injections in people with type 2 diabetes with poor glycemic control. Study results were published online in The Lancet today.
In the OpT2mise trial, those using insulin pumps achieved a mean A1C (average blood glucose) reduction of 1.1 percent compared to only a 0.4 percent reduction by those using multiple daily injections. This improvement in glucose control was achieved without any episodes of severe hypoglycemia. In addition, those in the insulin pump group lowered the total daily dose of insulin by more than 20 percent. There was no difference in weight gain between the two groups.
Reducing A1C is critical for people with diabetes because even small percent drops aid significantly in preventing complications, such as eye disease, kidney disease, nerve damage and heart attacks
"For these patients, insulin pump technology is therefore a valuable option with proven benefits over simply continuing adjustments of an MDI (multiple daily injection) regimen," said Dr. Ronnie Aronson of LMC Diabetes & Endocrinology, Toronto, Canada, one of the study authors. "Insulin pump use can safely reduce HbA1c, with less insulin, and without increasing hypoglycemia and should take a spot in the care path for our type 2 diabetes patients who need advanced insulin management."
Approximately 20 million people around the world with type 2 diabetes require insulin replacement therapy and adherence to insulin therapy can be a challenge, with 57% of patients on MDI therapy admitting to omitting insulin injections
The global, randomized, controlled study was sponsored by Medtronic and conducted with participation from 331 patients, ranging in age from 30 to 75 years. Eight centres across Canada participated in the study. Specific results include:
- Those using insulin pumps demonstrated a mean reduction of A1C levels by 1.1 percent, vs. only 0.4 percent for participants using multiple daily injections (P < 0.001).
- Those in the CSII arm experienced the A1C reduction without any episodes of severe hypoglycemia (low blood sugar, which can cause confusion, disorientation, loss of consciousness, and in the worst cases coma and even death) or ketoacidosis (a potentially life-threatening condition caused by hyperglycemia or high blood sugar).
- The total daily insulin dose was 20.4% lower with CSII than with injection therapy (P < 0.001) with no significant difference in body weight change between the two groups.
- The percentage of participants in the CSII group achieving an A1C < 8% was twice that of the multiple daily injections group (55% vs. 28%).
"As Medtronic continues to expand into providing more solutions for people living with type 2 as well as type 1 diabetes, collaborating with the world's experts to build a clinical body of evidence to help guide therapy for all people with diabetes is very important," said Francine R. Kaufman, M.D., Chief Medical Officer and Vice President of Global, Clinical and Medical Affairs for Medtronic Diabetes. "OpT2mise is the latest example of this clinical leadership and a trial that has the potential to help improve access to insulin pump technology for the many people with type 2 diabetes who could benefit."
About the Diabetes Business at Medtronic of Canada
The Diabetes business at Medtronic of Canada (www.medtronicdiabetes.ca) is the Canadian leader in advanced glucose monitoring and control solutions, including insulin pump technology, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 consumer and professional service and support.
About Medtronic of Canada
Medtronic of Canada Ltd. (www.medtronic.ca) is a trusted Canadian leader delivering innovative health system solutions and advanced medical technologies to alleviate pain, restore health, and extend life in the areas of cardiovascular medicine, diabetes, spinal and neurosurgery, and ear, nose, throat surgery. Medtronic is proud to employ more than 700 Canadians. Headquartered in Brampton, Ontario, Medtronic has regional offices in Vancouver and Montreal, including a manufacturing facility, Medtronic CryoCath, located in Pointe-Claire, Quebec.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW (2008). 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med; 359:1577-1589