New Data Shows Benefits of Medtronic Insulin Pumps for People with Type 2 Diabetes
April 13 2016 - 9:00AM
Study Shows
Insulin Pumps Safely Provided Significant, Sustainable and
Reproducible Improvements in Glucose Control in Comparison to
Multiple Daily Injections
DUBLIN - April 13, 2016 -
Medtronic plc (NYSE:MDT), the global leader in medical technology,
today announced the publication of new data in Diabetes, Obesity and Metabolism from the continuation
phase of the OpT2mise study, providing further clinical evidence in
support of insulin pumps for people with insulin-requiring type 2
diabetes. The OpT2mise study is the largest randomized
controlled trial to compare the efficacy and safety of insulin pump
therapy versus multiple daily injections (MDI) for poorly
controlled type 2 patients.
Study findings showed that MiniMed® insulin
pumps safely provided significant, sustainable and reproducible
improvements in glucose control in comparison to MDI. At 12 months,
the group that crossed over to MiniMed insulin pumps after an
initial six months of MDI doubled their A1C reduction (a blood
measurement used to indicate glucose control) from 0.4% to 0.8%
while using 19% less insulin.
"The continuation phase of OpT2mise builds on the
findings of the initial study period, which showed that insulin
pumps helped participants with insulin-requiring type 2 diabetes
safely achieve better glucose control, with lower insulin doses,
than MDI," said Ronnie Aronson MD, FRCPC, FACE, lead author of the
continuation phase of the study and executive director at LMC
Diabetes & Endocrinology in Toronto, Ontario, Canada. "We found
that participants who switched from MDI to insulin pumps were able
to achieve these same results by the 12-month mark. Given that many
patients with type 2 diabetes have difficulty achieving glycemic
control, these additional data demonstrate that insulin pumps
provide a significant advantage over MDI with a safe and consistent
effect."
For people with diabetes, glucose control is key
to preventing both short-term and long-term complications. A 1%
reduction in A1C is associated with a reduction in the risk of
long-term complications like stroke, heart disease, eye damage and
kidney disease reduces by 40%. 1,2
Initial results of OpT2mise showed that after six
months, people with insulin-requiring type 2 diabetes who used
MiniMed insulin pumps achieved better glucose control than those
using MDI. Results after one year include:
- Glucose control improved significantly for all
patients. Patients receiving MDI for the initial six months of the
study were able to achieve an additional A1C reduction of 0.8%
(p<0.0001) after switching to insulin pump therapy; both groups
achieved an identical 1.2% reduction in A1C at the 12-month mark
compared to the baselines.
- The clinical benefit from pump therapy was
reproducible. The MDI group, which switched to insulin pump therapy
after six months, experienced a similar reduction in A1C to the
results seen in the original insulin pump group. Additionally, at
the end of the continuation phase, participants who switched from
MDI to insulin pump showed a 19.0% reduction in total daily insulin
dose, making it equivalent in both treatment arms.
- Glucose control with pump therapy was sustained
over 12 months. The original pump group had a further 0.1%
reduction in A1C to attain a final 12-month value of 7.8%. There
was no difference between groups in weight gain.
"At Medtronic Diabetes we are looking at how we
can deliver greater freedom and better health for all people with
diabetes, including those living with type 2," said Francine R.
Kaufman, M.D., chief medical officer and vice president of global,
clinical and medical affairs for Medtronic Diabetes. "The results
of the OpT2mise trial, which is the largest study of its kind, will
help us expand access to insulin pump therapy as a standard of care
treatment for the growing number of insulin-taking type 2 diabetes
patients so they can enjoy improved clinical outcomes."
About OpT2mise
The randomized, controlled OpT2mise study was sponsored by
Medtronic and conducted with participation from 331 patients,
ranging in age from 30 to 75 years. Initial six-month study results
comparing MiniMed insulin pump therapy to MDI were published in
The Lancet in July 2014. During the six-month
continuation phase of the study, the MDI group was switched to
MiniMed pump therapy and follow-up of both groups was continued,
making a total study period of 12 months.
About the Diabetes Group at
Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change
the way people manage diabetes. The company aims to transform
diabetes care by expanding access, integrating care and improving
outcomes, so people living with diabetes can enjoy greater freedom
and better health.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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.
-end-
1 UK
Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose
control with sulphonylureas or insulin compared with conventional
treatment and risk of complication in patients with type 2 diabetes
(UKPDS 33). Lancet. 1998; 352:837-853.
2 The post
trial monitoring results: 10 years follow up: Holman RR, Paul SK,
Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive
glucose control in type 2 diabetes. N Engl J
Med. 2008; 359:1577-1589.
Contacts:
Pamela Reese
Public Relations
+1-818-576-3398
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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