New basal insulins Are they any better? Matthew C. Riddle, MD Professor of Medicine Oregon Health & Science University Keystone Colorado 15 July 2011

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1 New basal insulins Are they any better? Matthew C. Riddle, MD Professor of Medicine Oregon Health & Science University Keystone Colorado 15 July 2011

2 Presenter Disclosure I have received the following forms of support: Research grants Honoraria for consulting Honoraria for speaking Amylin, GSK, Lilly, Sanofi-Aventis Amylin, Lilly, Roche, Sanofi-Aventis Llilly, Sanofi-Aventis

3 New basal insulins: Are they any better? Maybe! But the ways we use them need work too!

4 New long-acting insulins Glargine Detemir Degludec LY Concentrated insulins (U500 Regular human, U300 Glargine, U200 Degludec)

5 A-chain B-chain Long-acting insulin analogues Human Insulin Dimers and hexamers in solution Gly Arg Arg Glargine Soluble at low ph Precipitates at neutral (subcutaneous) ph C-14 myristic acid Detemir Increased self-aggregation Binds to albumin L-γ-Glu C-16 hexadecanoic acid desthrb30, LysB29Nξ-hexadecandioyl-γ-Glu human insulin Degludec Increased self-aggregation Binds to albumin

6 Outline of this talk How successful are current long-acting insulins? What have we learned about degludec? What other barriers limit success of insulin therapy?

7 Basal and postprandial insulin secretion Both are abnormal in type 2 diabetes 400 Glucose Normal Type 2 Diabetes 120 Insulin mg/dl U/mL B L S Time of Day B L S Time of Day Polonsky K et al. N Engl J Med 1988;318:

8 Basal or basal-bolus insulin treatment U/mL Prandial insulin Normal pattern 20 Basal insulin Time of day

9 Long-acting insulin analogues Mechanisms of protraction of action Delayed absorption from sc space Decreased clearance from plasma Delayed clearance from interstitial space NPH Yes No No Glargine Yes No No Detemir Yes Yes Yes Degludec Yes Yes Yes?

10 Desired characteristics for a basal insulin Long-duration Low variability Flat action curve Day-to-day consistency Between-patient consistency Clinical effectiveness A1c reduction Limited hypoglycemia

11 Current long-acting insulins Action profiles

12 Action profiles of long-acting human insulins NPH hours Ultralente ~24 hours Hours

13 Action profiles of ultralente, NPH, glargine Single-dose studies in 20 patients with type 1 diabetes Glucose infusion mg/kg/min 4 3 NPH Ultralente Glargine Hours Lepore M et al. Diabetes 2000;49:

14 Action profiles of detemir and NPH Single-dose studies in 12 type 1 patients GIR mg/kg/min Detemir 0.1 U/kg Detemir 0.2 U/kg Detemir 0.4 U/kg NPH 0.3 IU/kg Hours after injection Plank J et al. Diabetes Care 2005;28:

15 mu Kg -1 min Action profiles of detemir and glargine 2-week treatment in 24 patients with type 1 diabetes s.c. insulin 0.35 U/Kg Detemir Glargine Insulin infusion rate mu Kg -1 min -1 mg Kg -1 min Glucose infusion rate Detemir Glargine INFUSION RATE mmol Kg -1 min Porcellati F et al. Diabetes Care 2007;30: Hours 0

16 mg/dl Glucose profiles with detemir and glargine 2-week treatment in 24 patients with type 1 diabetes s.c. insulin 0.35 U/Kg Plasma glucose Detemir mmol/l Glargine Subjects with plasma glucose N > 150 mg/dl at end % Porcellati F et al. Diabetes Care 2007;30: Hours Detemir Glargine

17 Action profiles of long-acting insulins NPH hours Detemir hours? Ultralente ~24 hours Glargine 24+ hours Hours

18 Action profiles of longer-acting insulins Detemir hours Glargine 24+ hours Hours

19 Current long-acting insulins Variability

20 Measures of glycemic variability Within-day -- relative to 24-hr means Between-day -- area under action curve Between individuals profile and AUC

21 GIR mg/kg/min Action profiles of glargine Repeated single-dose studies in nondiabetic persons Scholtz HE et al. EASD 1999, Abst. 882

22 Action profiles of detemir Repeated single-dose studies in patients with type 1 diabetes GIR mg/kg/min Subject no: Subject no: Subject no: Subject no: 210 Subject no: 212 Subject no: Clamp 1 Clamp 2 Clamp 3 Clamp U/kg in thigh Subject no: 220 Subject no: 223 Subject no: Heise T et al. Diabetes 2004;53: Hours

23 Variability of basal insulins Insulin action by clamp study Glargine Longer duration, lower peak Moderate within-day variability Moderate between day variability Significant between-individual variability Detemir Shorter duration, higher peak Greater within-day variability Lower between-day variability Significant between-individual variability

24 U 500 Regular human insulin Pharmacokinetic and pharmacodynamic study N=24 healthy obese subjects Mean age 40, BMI 34 kg/m 2 Randomized, masked, crossover comparison U-100 R 50 units or U-100 R 100 units vs U-500 R 50 units or U-500 units Findings: 1) At these doses, duration of action approaching 24 hours with both insulins 2) Equivalent total exposure (PK) and effect (PD) 3) Lower peak and greater effect hours with U-500 Jackson JA et al. Late-breaking abstract ADA Scientific Sessions June, 2010

25 Current long-acting insulins Clinical studies

26 Mean FPG mg/dl mmol/l Treat-to-Target Trial Basal insulin added to 1-2 oral agents Response of fasting plasma glucose Glargine Weeks of treatment NPH 6.5, 6.7 mmol/l 117, 120 mg/dl Riddle MC et al. Diabetes Care 2003;26:

27 Treat-to-Target Trial Basal insulin added to 1-2 oral agents Response of A1c A1c % Glargine NPH 8 6.9, 6.9 % 7 58% 7% Riddle MC et al. Diabetes Care 2003;26: Weeks of treatment

28 Treat-to-Target Trial Hypoglycemia over time Cumulative confirmed events Riddle MC et al. Diabetes Care 2003;26:

29 Treat-to-Target Trial Hypoglycemia by time of day Confirmed events per patient-year Insulin injection * * * * * * * Glargine NPH * p < Riddle MC et al. Diabetes Care 2003;26: Time of day

30 Relationship of A1c to hypoglycemia in T2DM Meta-regression model comparing NPH vs glargine Subject-level data from 3175 patients in 6 large trials adjusted for covariates 200 Hypoglycemia confirmed <65 mg/dl (events per 100 patient-years) NPH P = Glargine A1c % Mullins et al. Clin Ther 2007;29:

31 Glargine vs Detemir added to OAD in T2DM 11 Glucose profiles FPG mmol/l 9 7 Mean insulin dosage Glargine 0.44 units/d Detemir 0.78 units/d SMBG mmol/l weeks Number of injections Glargine 100% QD Detemir 45% QD 55% BID 5 acb pcb acl pcl acd pcd HS Noc1 Noc2 acb Rosenstock J et al. Diabetologia 2008;51:

32 Glargine vs Detemir added to OAD in T2DM Achieved FPG and A1c FPG A1c FPG mmol/l % Baseline Det Glar 6 Baseline Det Glar Rosenstock J et al. Diabetologia 2008;51:

33 Glargine vs Detemir added to OAD in T2DM % at target, hypoglycemia, and weight A1c <7% A1c <7% no hypos 10 5 Hypogycemia events/pt-yr weight kg Det Glar Det Glar 0 Det Glar 0 Det Glar Rosenstock J et al. Diabetologia 2008;51:

34 Apparent characteristics of long-acting insulin analogues Detemir Glargine Long-duration hr 24+ hr QD or BID QD Low variability Flat action curve No Nearly Day-to-day consistency Good Moderate Between-patient consistency Fair Good Clinical effectiveness A1c reduction Good Good Limited hypoglycemia Good Good

35 What have we learned about degludec?

36 Peer-reviewed clinical reports Zinman B et al. Lancet 2011;377: Degludec QD or 3x/wk vs Glargine QD added to OAD in T2DM N=245 Heise T et al. Diabetes Care 2011;34: Degludec 70/30 QD vs Glargine QD added to OAD in T2DM N=178 Birkeland KI et al. Diabetes Care 2011;34:661-5 Degludec QD vs Glargine QD with TID Aspart in T1DM N=178

37 Degludec QD or 3x/wk (acd or HS) vs Glargine QD (HS) added to OAD in T2DM A1c % FPG mmol/l Baseline 16 weeks Baseline 16 weeks SMBG profiles mmol/l B L D HS B Zinman B et al. Lancet 2011;377:924-31

38 Degludec-Aspart 70/30 acd vs Glargine HS added to OAD in T2DM A1c % % at A1c target <7.0% G D-A <6.5% G D-A <7.0% G D-A 16 weeks <6.5% G D-A % at A1c target without confirmed hypoglycemia after 12 weeks Heise T et al. Diabetes Care 2011;34:669-74

39 Degludec-Aspart 70/30 acd vs Glargine HS added to OAD in T2DM SMBG profiles mmol/l Heise T et al. Diabetes Care 2011;34:669-74

40 Degludec QD vs Glargine QD (acd or HS) with TID Aspart in T1DM Δ A1c % Baseline 16 wks Birkeland KI et al. Diabetes Care 2011;34:661-5

41 Degludec QD vs Glargine QD (acd or HS) with prandial Aspart in T1DM Confirmed hypoglycemia <3.1 mmol/l (56 mg/dl), events/patient-yr All events Glargine Degludec B Degludec A Nocturnal events Glargine Degludec B Degludec A Baseline 16 wk Birkeland KI et al. Diabetes Care 2011;34:661-5

42 A1c and fasting plasma glucose at 16 weeks Glargine QD Degludec QD FPG mol/l (mg/dl) Zinman et al (T2DM) 6.3 (113) 6.4 (115) Birkeland et al (T1DM) 8.9 (160) 8.3 (149) A1c % Zinman et al (T2DM) Birkeland et al (T1DM)

43 Hypoglycemia confirmed < 3.1 mm (56 mg/dl) Glargine QD Degludec QD Incidence (% of patients) Zinman et al (T2DM) 23% 8% Rate (events/pt-yr) Zinman et al (T2DM) Birkeland et al (T1DM) 66 48

44 Apparent characteristics of long-acting insulin analogues Detemir Glargine Degludec Long-duration hr 24+ hr 48+ hr QD or BID QD QD or 3x/wk Low variability Flat action curve No Nearly Yes Day-to-day consistency Good Fair? Between-patient consistency Fair Good? Clinical effectiveness A1c reduction Good Good Good Limited hypoglycemia Good Good Better?

45 What are the other barriers?

46 Barriers to success of insulin therapy (other than imperfect pharmacodynamics) Titration of dosage Adherance to regimen Treatment of postprandial hyperglycemia

47 Dropout rates in basal insulin studies with a Treat-to-Target design in T2DM Duration (wk) Riddle et al 2003 NPH 24 8 Glargine 24 9 Rosenstock et al 2008 Glargine Detemir Zinman et al 2011 Glargine 16 8 Degludec Heise et al 2011 Glargine 16 8 Degludec 16 7 % dropout

48 Mean dosage of basal insulin in studies with a Treat-to-Target design in T2DM Units/day Riddle et al 2003 NPH Glargine Rosenstock et al 2008 Glargine Detemir Zinman et al 2011 Glargine Degludec Heise et al 2011 Glargine Degludec Units/kg/day

49 Postprandial hyperglycemia persists after basal therapy 164 T2DM patients with baseline A1c 7.5% studied after 3 months intensification of diet, oral, insulin treatment Glucose mg/dl A1C >7% (n=44) A1C 7% (n=120) 100 Woerle HJ et al. Diabetes Res Clin Pract 2007;78: Hours

50 Basal insulin with oral agents as a platform for adding prandial therapy Various options Progression to basal-bolus insulin Rx Rosenstock J et al. Diabetes Care 2008;31:20-25 Adding prandial insulin with the main meal Owens D et al. Diab Obes Metab 2011;13 (in press) Adding pramlintide Riddle MC et al. Diabetes Care 2009;32: Adding short or intermediate-acting GLP-1 agonist Buse JB et al. Ann Intern Med 2011;154: Adding SGLT-2 inhibitor?

51 Which patients might best use improved long-acting analogues? Foreseeing the future One size does not fit all High benefit vs risk? Type 1 or long-duration type 2 Slender, low insulin dose Consistent activity schedule Low benefit? Short duration type 2 Obese, insulin resistant High risk? Slender type 1 Highly variable activity Highly variable eating Poor decision-making

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