Opt2mise

Opt2mise 1

Dr. Bode Webinar

 

OpT2mise: the largest randomized, controlled study on insulin pump therapy for type 2 diabetes*


36 international centers around the globe
Objective
  • Compare the efficacy and safety of pump therapy and multiple injection therapy in patients with type 2 diabetes who had failed to respond to a basal-bolus regimen after active insulin titration.
Primary End-point
  • Between-group difference in mean change in A1C from baseline to 6 months.
  • Δ Pump A1C - Δ MDI A1C.
Design
  • Subjects: 331 adult patients randomized (35-75 years old)
  • Duration: 6 months
  • Location: 36 international centers
  • Results delivered with MiniMed® insulin pump
Patient Population
  • Insulin-taking patients with type 2 diabetes on MDI (>3 injections/day)
  • 8.0% ≤ A1C ≤ 12.0%
  • Insulin dose: 0.7-1.8 units/kg/day
  • Mean SMBG ≥ 2.5 times/day

Aronson R, Cohen O, Conget I, et al. OpT2mise: A randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes. Diabetes Technol There. 2014;16:414-420 doi:10.1089/dia.2013.0363.
*Results achieved do not guarantee results in all prospective new patients; variability as between patients is possible.

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Only MiniMed insulin pump therapy is clinically proven to reduce A1C* better than MDI1


MiniMed insulin pump therapy chart

Efficacy



1.1%
A1C drop with MiniMed insulin pump therapy versus 0.4% in the group on multiple daily injections

0.7 % between groups difference in A1C in favor of MiniMed insulin pump therapy

Patients that achieved A1C <8%
2x
Almost twice as many patients achieve A1C < 8% with MiniMed insulin pump therapy

*Results achieved do not guarantee results in all prospective new patients; variability as between patients is possible.
1Reznik Y, Cohen O, Aronson R, et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomized open-label controlled trial. The Lancet. 2014. DOI 10.1016/S0140-6736(14)61037-0.

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Safety

No severe hypoglycemia events with MiniMed insulin pump therapy and no increase in the time spent in hypoglycemia
No ketoacidosis events with MiniMed insulin pump therapy

Other results

-20% total daily insulin dose reduction with MiniMed insulin pump therapy when compared with MDI
+8% increase of HDL-cholesterol concentration with MiniMed insulin pump therapy and - 7% decrease in the MDI group
No significant difference in body weight change with MiniMed insulin pump therapy

*Results achieved do not guarantee results in all prospective new patients; variability as between patients is possible.

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Potential long term benefit

Reducing A1C is critical for people with diabetes.

Studies have shown that A1C reduction can significantly reduce the occurrence of long-term complications.2, 3

Potential long term benefit

*Results achieved do not guarantee results in all prospective new patients; variability as between patients is possible.
2. 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). The Lancet 1998; 352:837-853.
3. 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.

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Patient clinical profile:

  • A1C between 8%-12%
  • Insulin requirements of 0.7-1.8 units/kg
  • Multiple daily injections therapy (3+ injections per day) with or without combination with other oral or non-insulin injectable agents.
  • Facing challenges to meet A1C goals despite dosing titrations over at least the last 3 months.

To download a copy of the OpT2mise clinical summary in PDF form Click Here.

To download a copy of The Lancet study Click Here. and enter your email address.
OpT2mise clinical summary in PDF

Reznik Y, Cohen O, Aronson R, et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomized open-label controlled trial. The Lancet. 2014. DOI 10.1016/S0140-6736(14)61037-0.

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Safety Information

Insulin infusion pumps and associated components of insulin infusion systems are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks of insulin pump therapy. Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day. Insulin pump users should have sufficient visual and audio acuity to recognize the alerts and alarms provided by the pump. Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.

Replace the infusion set every 48-72 hours, or more frequently per your healthcare professional’s instructions.

Please visit www.medtronicdiabetes.com/importantsafetyinformation for additional details.