Diabetes Prevention Program Outcomes Study Clinics

1. The Diabetes Prevention ProgramOutcomes Study:Our Contributions Carry OnLong-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High RiskThe DPP/DPPOS Research Group

2. Diabetes Prevention Program Outcomes Study Clinics . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Sponsors • National Institute of Diabetes & Digestive & Kidney Diseases • Other NIH Institutes, Offices • National Center on Minority Health and Health Disparities • National Institute of Child Health and Human Development • National Institute on Aging • National Center for Research Resources, GCRC Program • Office of Research on Women’s Health • National Eye Institute • National Heart Lung and Blood Institute • Other Federal Agencies • Indian Health Service • Centers for Disease Control and Prevention

4. Sponsors • American Diabetes Association • Industry grant support • Bristol-Myers Squibb • Additional Support • LifeScan, Inc • Lipha (Merck-Sante)

5. Study Timeline

6. DPP Primary Goal • To prevent or delay the development of type 2 diabetes in persons with impaired glucose tolerance (IGT)

7. DPP Study Treatment Groups Screen (158,177 people) Randomize (3,819 people) Standard lifestyle teaching Intensive Lifestyle (1079 people) Placebo (1082 people) Metformin (1073 people) Troglitazone 585 people Until 6/98

8. DPP Incidence of Diabetes Placebo (n=1082) Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Metformin, p<0.001 vs. Placebo) Risk reduction 31% by metformin 58% by lifestyle

9. Keys to DPP Lifestyle Success Weight loss was the key to diabetes prevention Reduction of total calories, especially fat calories Achieving 150 minutes of activity each week

10. Troglitazone Participants • There were fewer Troglitazone participants in DPP (n=585) than in the other groups (n~1000) since recruitment was stopped early • Treatment with Troglitazone only lasted for an average of 9 months and therefore the long term effects of Troglitazone on diabetes prevention are not known • During the brief period of Troglitazone treatment, development of diabetes was decreased by ~70% compared with Placebo

11. Bridge Period from DPP to DPPOS Summer 2001 - Fall 2002 All participants continued their DPP treatments Metformin participants completed medicine wash-out January - June 2002 All DPP participants were offered a 16-session Group Lifestyle Balance Program September 2002 Diabetes Prevention Program Outcomes Study begins

12. Who Joined DPPOS? 3251 DPP participants joined DPPOS 88% of the original DPP participants

13. Who Joined DPPOS at <insert clinic name> • <x> DPP participants joined DPPOS • <x>% of the original DPP participants

14. DPPOS Goals Diabetes delay or prevention Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease

15. DPPOS Treatments Original Placebo group HELP classes four times a year Original Metformin group Metformin 850 mg twice daily HELP classes four times a year Original Lifestyle group HELP classes four times a year Boost lifestyle classes twice a year

16. Weight Change Over Time

17. DPPOS Incidence of Diabetes

18. DPPOS Incidence of Diabetes

19. DPP vs. DPPOS Diabetes Rates

20. Diabetes Development in DPPOS Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during DPP. Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group.

21. DPPOS Diabetes Risk Reduction Delay in diabetes onset after 10 years follow-up: 4 years for Lifestyle 2 years for Metformin The lower rate of diabetes development for lifestyle and metformin during DPP means: Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo Original Metformin participants have a 19% lower risk of diabetes compared to Placebo

22. Diabetes Frequency After 10 years 52% of Placebo participants have diabetes 47% of Metformin participants have diabetes 42% of Lifestyle participants have diabetes

23. Use of Anti-diabetic Medicines

24. Heart Disease Risk All treatment groups have decreased blood pressure, cholesterol and triglycerides. Lifestyle participants had the same or lower blood pressure and lipid levels over time than other participants with less use of medicines.

25. DPP/DPPOS Publications Diabetes Prevention Program Public Website www. bsc.gwu.edu/dpp/pps/registry.cgi

26. Here’s what to expect next in DPPOS • A mid-year and annual visit each year • Four HELP classes each year • A set of retinal (eye) photos in 2012

27. Additional DPPOS Treatments • Two BOOST campaigns each year for original Lifestyle participants. • Metformin participants are asked to continue to take study metformin. • DPP troglitazone participants will no longer have clinic visits for outcomes testing.

28. New Outcomes Measures • Cognitive (Memory) Testing • Physical Function Testing

29. Individual Results Summary • Over the next six months, you will receive a summary of your DPP and DPPOS testing • DPPOS staff will review this information with you and answer your questions

30. Your Health Care • Research is not a substitute for health care. • See your Primary Care Provider regularly to make personal decisions about your health care. • If you have diabetes, continue your regular eye exams, foot exams, etc.

31. Thank You for Your Contributions to Diabetes Research and Prevention Your Contributions Carry On!