MiniMed™ Insulin Pump:

Significant HbA1c reduction for type 2 diabetes, now clinically proven1

MiniMed for TYPE

DIABETES

Do your type 2 patients, despite a multiple daily injection (MDI) regimen

and active insulin titration, still face challenges in meeting HbA1c targets?

Is MDI not well managed and not fulfilling your patients’ needs?

Discover how MiniMed™ pump could help.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use

Amputation or Death

from peripheral

vascular disease

Fatal and Non-fatal

Myocardial infarction

Death Related to Diabetes

Any Endpoint Related to Diabetes

Micro- vascular

50

40

30

20

10

0

Risk

Red

uctio

n (%

)

-37%

-21% -21%

-14%

-43%UKPDS: United Kingdom Prospective Diabetes Study.

The OpT2mise study2

The Medtronic-sponsored OpT2mise study is the largest (331 patients) randomized, controlled trial on insulin pump therapy for type 2 diabetes. This international, multicenter (36 centers around the globe), parallel-group study consisted of a run-in period, a six-month randomized phase and a six-month continuation phase.

The study results1

The study concluded that MiniMed Pump Therapy can significantly improve glycemic control, compared with MDI strategies, in patients with T2 diabetes who are unable to reach glycated haemoglobin goals.

MiniMed Pump Therapy has been proven to be effective and safe: it might therefore be considered a valuable therapeutic option in this population.

Study Schedule

121110987654321Month

Run-in Optimization

Treatment: CSII

Control: MDI

Study phase 6 months Continuation phase 6 months

Single Arm Cross MDI to CSII

Randomization

8

36

17

2

331 patients36 centers around the globe

“This study provides a compelling case for the clinical effectiveness of CSII [continuous subcutaneous insulin infusion] in type 2 diabetes, suggesting that it can help improve glycemic control in this difficult cohort of patients with poor control despite efforts at

increasing insulin dose. Although other options such as GLP-1RA [glucagon-like peptide 1-receptor agonists] and bariatric surgery are available, these will be unsuitable or not

tolerated by a significant proportion of patients. In these patients, CSII offers a higher chance of optimization of glucose control and should be considered as a viable and effective option.”

Dr Pratik Choudhary, Diabetes Research Group, King’s College London, Weston Education Centre, London, UK – Extract from Continuous subcutaneous insulin infusion for type 2 diabetes, comment to The Lancet article, 3rd July 2014

SAFETY

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

No ketoacidosis event with MiniMed insulin pump therapy

1.1 % HbA1c drop with MiniMed insulin pump therapy versus a 0.4% drop in the group on MDI

0.7 % between groups difference in HbA1c in favor of MiniMed insulin pump therapy

EFFICACY

1.1%

0.7%

7

8

9

10 CSII

MDI

- 8 0 3 15 27

Run-in (8 weeks)

Study Phase (6 months + 3 weeks)

Mea

n A

1C a

nd 9

5% C

.I. (

%)

Week

MDI 8.6%

Baseline 9.0%

CSII 7.9%

55% 28%Patient group on MiniMed insulin pump therapy

Patient group on Multiple Daily Injections (MDI)

Patients that achieved HbA1c <8%

Almost twice as many patients achieve HbA1C < 8% with MiniMed insulin pump therapy

X2

Reducing HbA1c is critical for people with diabetes.

1.1% drop in HbA1c is associated with significant reduction in diabetes-related complications such as eye disease, kidney disease, nerve damage and heart attacks3,4

POTENTIAL LONG-TERM BENEFIT

UKPDS: United Kingdom Prospective Diabetes Study; MI: myocardial infarction; PVD: peripheral vascular disease.

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

+8%

MiniMed insulin pump therapy is clinically proven to reduce HbA1c better than multiple daily injections for people with type 2 diabetes suboptimally controlled1

20.4%LOWER

COMPARED WITH MDI

NO SIGNIFICANTDIFFERENCE

57%

of people taking insulinwith MDI openly admit to omittinginsulin injections.5

Patient clinical profile:

• HbA1c between 8% -12%

• I nsulin requirements of 0.7-1.8U/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 HbA1c goals despite dosing titrations over at least the last 3 months

Patient behavioral parameters:

• Patient shows dissatisfaction and/or difficulty adhering to current medication regimen

• He/She has an active life and finds it difficult to fulfill the requirements of MDI

• He/She often forgets to bolus at meals and can’t follow a regular diet regimen

• He/She is motivated and willing to monitor blood glucose since concerned about long-term complications

20%

More than 20% of people taking insulin with MDI admit that injections interfere with their daily life, creating anxiety and discomfort.5

In the OpT2mise study, older age, longer duration of diabetes, low cognitive score and low SMBG use did not diminish the positive effect of CSII therapy6

Type 2 candidates for MiniMed insulin pump therapy Your type 2 patients on MDI therapy might be candidates for MiniMed pump therapy if:

“A better glucose control has positive long-term health consequences on diabetes burden including cardiovascular and diabetes-related microvascular complications. Our findings open up a valuable new treatment option for those individuals failing on current injection regimens and may also provide improved convenience, reducing the burden of dose tracking and scheduling, and decreasing insulin injection omissions.”

Prof. Yves Reznik, OpT2mise investigator, Department of Endocrinology, University of Caen Côte de nacre Regional Hospital Center, Caen, France

Meet John and Janis, type 2 diabetes patients and discover how their lives have been changed thanks to the MiniMed Pump.

Janis

John

The MiniMed pump has been wonderful for me. It keeps my numbers down and I can do whatever I want to do. It gives me freedom and better control

Using the MiniMed pump has allowed me to get tighter control of my blood glucose levels with less interaction in dealing with taking multiple daily injections and oral medications

My glycated hemoglobin has improved. Today, on MiniMed pump therapy, is 6.4%. It was 9.1% on multiple daily injections

My glycated hemoglobin has improved. Today, on MiniMed pump therapy, is between the range 6.2% - 7.2%. It was 9.2% on multiple daily injections. I have reduced my daily insulin intake to 170 units. It was 220 units on multiple daily injections

I am in better control with my MiniMed pump since 2009, when I made the switch from multiple daily injections

I am in better control with my MiniMed pump since 2013, when I made the switch from multiple daily injections

2009

2013

IN BETTER CONTROL WITH MINIMED PUMP SINCE 2009

IN BETTER CONTROL WITH MINIMED PUMP SINCE 2013

PROFILE

PROFILE

MiniMed™ 640G features to adapt to type 2 diabetes therapyHigh insulin needs

• With 3ml/300 units capacity, usage of insulin reservoir is maximized and changes minimized.

• Max bolus of 75 units to meet also high insulin needs combined with • High bolus speed (15 units/minute. Max bolus delivered in 5 minutes)• Multiple basal rates to best meet their insulin needs

Simplicity & support

• Up to 8 Preset Bolus amounts, easy to access and deliver• The Missed Meal Bolus Reminder will help to ensure that your patients don’t miss

a dose.

Convenience and discretion

• Possible to deliver an insulin bolus discreetly from Bayer Contour® Next LINK 2.4 meter or on the pump with few simple button pushes

• Volume adjustable for alarms and vibration mode available• Full color screen• Self adjusting display that adapt to lightIf your patient suffers from DEXTERITY IMPAIRMENT, this feature could be useful• Key pad with tactile recognizable button and usable by both right and left handed

*At baseline, 64 (38%) patients in the pump treatment group and 64 (39%) in the multiple injection group

had abnormal scores on the Montreal Cognitive Assessment test, indicative of mild cognitive impairment.

Both groups had a similar fall in glycated haemoglobin and a similar increase in total insulin daily dose

during the run-in period1.

MiniMed insulin pump therapy provides better control1 and is easy to learn and use, which may lead to improved patient satisfaction and better adherence to your therapy plan.

MiniMed pump: convenient therapy management for your type 2 patients You may think your type 2 patients aren’t qualified for insulin pump therapy.

The truth, however, is that it can be less demanding than taking multiple daily injections.

For example, OpT2mise study also demonstrated that even the subgroup of patients with mild cognitive impairments experienced benefit in HbA1c reduction similar to general population by using MiniMed pump therapy*.

• Only 10 to 12 infusion set changes instead of up to 120-150 injections per month

• Meal time insulin is delivered painlessly and discreetly with

a few simple button presses. Anywhere and in every situation

MiniMed pump therapy can help reduce patients’

anxiety and discomfort of insulin taking. This can improve their adherence

to therapy

“MDI today is not always providing an ideal solution for all type 2 patients. Pump therapy with MiniMed pump has improved control for these patients. For years it has been common thought that pump would apply to type 1 patients only. OpT2mise study results instead show that the pump could be a good option and effective tool for type 2 patients as well. Patients’ acceptance of the pump was excellent. After the study, most of them did not want to go back to MDI”

Prof. Ohad Cohen, OpT2mise investigator, Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel

• treatment convenience

• flexibility

• understanding of diabetes

• willingness to recommend the treatment

• satisfaction to continue treatment

Patients treatment satisfaction7 Patients using MiniMed Pump therapy reported increased satisfaction of diabetes treatment with significant improvements in:

Willingness to Recommend

the Treatment

Understanding of diabetes

FlexibilityTreatment convenience

Satisfaction to Continue the

Treatment

Perceived Hyperglycemia

Perceived Hypoglycemia

Overall Satisfaction

p<0.05 p<0.0001 p<0.0001p<0.05

p<0.0001 p<0.0001

p<0.0001

NS

0

2

1

3

4

5

6

CSII

MDI

Scale 0 to 6

Convenient for your practiceWith the Type 2 Pumping Protocol Getting 2 GoalSM, MiniMed insulin pump therapy can be made simple and convenient for you and your diabetes care team, with options to advance therapy if desired.

It provides a simplified approach for initiating insulin pump therapy.

A flexible approach to bolus options and multiple basal rates allows a customized approach for your patients, based on their individual needs.

CareLink™ Pro provides easy-to-interpret trend reports for glycemic data and behavior patterns.

Take the guess work out of your patients’ compliance to their prescribed regimen. Evaluate their compliance to insulin therapy via CareLink reports.

Give your type 2 patients the

opportunity for a better control.

Evaluate with them the therapy with MiniMed pump.

Why MiniMed™?• For over 25 years, Medtronic has offered products with unique features and support,

confirming leadership in innovation in insulin pump therapy and integrated system and always having patients’ needs as first priority.

• Customer support and service to help improve the quality of your practice and outcomes for your patients.

• Education and training programs for patients and HCPs.

• CareLink™: CareLink™ Pro provides easy-to-interpret trend reports for glycemic data and behavior patterns.

Getting2GoalSM Type 2 Diabetes Pumping Protocol

A simplified approachto insulin pump therapyfor patients withtype 2 diabetes

MiniMed for TYPE

DIABETES

References

1. Reznik Y. Cohen O. Aronson R. et al. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open label controlled trial. Lancet 2014 Volume 384, Issue 9950, P. 1265 - 1272, 4 October 2014

2. 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-Research Design and Methods. Diabetes Technol Ther 2014 Jul;16(7):414-20. doi:10.1089/dia.2013.0363. Epub 2014 Apr 15

3. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998 Sep 12;352(9131):837-53

4. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008 Oct 9; 359(15):1577-89

5. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care, 2010 Feb;33(2):240-5

6. Factors associated with successful continuous subcutaneous insulin infusion therapy in type 2 diabetes patients - the OPT2MISE trial - Cohen at al. Presented at EASD 2014.

7. OpT2mise study: The Impact of Insulin Pump Therapy on Treatment Satisfaction and Resource Utilization in Patients with Type 2 Diabetes – Aronson et al. Presented at EASD 2014.

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