Insulin Therapy In Type 2 DM. Sources of support. Agenda. Michael Fischer, M.D., M.S. The underuse of insulin Insulin definition and types

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1 Insulin Therapy In Type 2 DM Michael Fischer, M.D., M.S. Sources of support NaRCAD is supported by a grant from the Agency for Healthcare Research and Quality My current research projects are funded by AHRQ and NIH institutes I do not accept personal compensation of any kind from any pharmaceutical companies, health insurers, or device manufacturers. DoPE accepts occasional unrestricted research grants from drug companies or health insurance companies to study specific drug safety and utilization questions. Agenda The underuse of insulin Insulin definition and types When should insulin be initiated? When should insulin be initiated? Choosing an insulin regimen Insulin dosing Related agents

2 What is Insulin? Made in the pancreas, released when serum glucose concentration increases Leads to muscle and adipose tissue uptake of glucose and glycogen synthesis Increases glycogen synthesis in liver Increases fatty acid synthesis and esterification (fat production) Decreases gluconeogenesis, lipolysis, proteinolysis In Type 2 DM - insulin resistance or deficiency The Underuse of Insulin Many patients with diabetes will need insulin Patients in the UKPDS: Failed oral therapy at a rate of 5 to 10 % per year Among patients initially controlled with a single drug: 50 % required the addition of a second drug after three years 75 % needed multiple therapies by nine years to achieve the target A1C value NHANES: over 40% of patients with diabetes do not reach a goal of A1C < 7% Insulin often is not started even when doctors and patients are aware of poor glucose control Why So Much Resistance to Insulin? Doctors? Patients?

3 Why So Much Resistance to Insulin? Doctors: Fear of hypoglycemia Lack of time to instruct patient Sense of failure that other treatments did not work Belief that insulin should only be used when essential Patients: Fear of injection Low perceived efficacy Sign of treatment and lifestyle failure Insulin Preparations obtained by permission from McMahon and Dluhy, NEJM, 2007 Short and Rapid Acting Insulins: Prandial Insulins Short Acting: regular insulin onset in minutes; peak at 2-3 hours administer 30 minutes before eating Rapid Acting Analogs: lispro, aspart, glulisine more closely mimics human physiology onset in 15 minutes, peak in 1 hour administer with food

4 Insulin Preparations obtained by permission from McMahon and Dluhy, NEJM, 2007 Intermediate and Long-Acting Insulins (Basal Insulins) Intermediate Acting NPH insulin Onset 2-4 hours, peak 6-8 hours, duration 16 to 20 hours Given once or twice daily Long Acting Glargine or Detemir Onset in 1 hour, no significant peak, duration 20 hours (Detemir) or 24 hours (Glargine) Insulin Preparations obtained by permission from McMahon and Dluhy, NEJM, 2007

5 Ultra long-acting Insulin New basal insulin formulation Long-acting profile (~40 hrs) Studies with dosing 1-3 times per week Not FDA approved as of spring Pre-Mixed (Biphasic) Insulin A fixed-ratio of faster and slower acting insulins Both human and newer insulin analog preparations Generally given twice a day Cannot tailor therapy to individual needs constrained by the concentrations When Should Insulin be Initiated? The ADA guidelines recommend starting insulin if: A1C > 8.5 on one oral hypoglycemic medication, Or A1C> 8.0 on two oral medications, Consider insulin if A1C is on 2 maximally dosed oral hypoglycemics Schwartz et al found that adding insulin is less expensive and leads to better control than adding a 3 rd oral medication (Diabetes Care, 2003)

6 When to consider 3 oral meds Spring statement from ADA endorses addition of 3 rd oral medication as alternative to adding insulin May be more patient-centered Acknowledges that transition to insulin likely to be more effective Inzucchi, Diabetes Care, When Else Should Insulin be Initiated? If Patient Is pregnant, Requires high-dose glucocorticoids Is intolerant of oral hypoglycemic agents, Is hospitalized with an acute myocardial infarction or another acute illness, (intensive therapy) Is in a perioperative/intensive care setting, (intensive therapy) Choosing an Insulin Regimen: Bottom Line: S Start with NPH or long acting insulin at night Titrate up as needed

7 Choosing an Insulin Regimen: NPH vs Long-Acting Insulin Treat-to-Target Trial 24-week study randomized 756 Type 2 diabetics who were: overweight had inadequate glycemic control (A1C 7.5% to 10%) on one or two oral agents Subjects received bedtime glargine OR NPH insulin Very SIMPLE algorithm for dose and titration Compared mean fasting blood glucose levels and A1C levels Choosing an Insulin Regimen: NPH vs. Long-Acting Insulin l i h NPH i li Treat-to-Target Trial achieved target (A1C levels of 7%) in about 60% of patients in each group slightly more hypoglycemia in Figure in video; for original, see Figure 1 in Riddle MC et al., The Treat-to-Target Trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care, 2003;26; NPH group, but not severe hypoglycemic episodes Riddle MC, Diabetes Care 2003 Similar Treat-to-Target trial with NPH and detemir had similar findings Hermansen, Diabetes Care 2006 Choosing an Insulin Regimen: NPH vs Long-Acting Insulin LANMET study Randomized type 2 diabetics with poorly controlled glucose on oral hypoglycemics to: NPH + metformin vs. glargine + metformin Findings: Glucose control similar More hypoglycemic events in the first 12 weeks in NPH group, but no difference in rates by week 36 Yki-Jarvinen, Diabetalogia 2006.

8 Choosing an Insulin Regimen: NPH vs. Long-Acting Insulin No significant difference in blood glucose control, mortality, morbidity, or quality of life No difference in severe hypoglycemic events Only 1-3 severe hypoglycemia events per 100 person years with NPH Small but statistically significant difference in rates of hypoglycemia Horvath, Cochrane Rev., 2007 In most patients, there is little clinical data to support choosing long-acting over NPH Choosing an Insulin Regimen: Biphasic or Prandial vs. Basal Insulin The 4-T Trial (NEJM, Oct., 2007) Pts. poorly controlled on orals were randomized to: detemir, prandial insulin, or biphasic insulin Pts. in biphasic i and prandial arms reached target t more than those in the basal arm, (17.0%, 23.9%, and 8.1%, respectively) benefits only in patients with a starting A1C > 8.5 also found more hypoglycemia and weight gain (4.7 kg, 5.7 kg, 1.9 kg, respectively) Choosing an Insulin Regimen: Prandial vs. Basal Insulin APOLLO Trial (Lancet, 2008) 418 inadequately controlled type 2 diabetics Randomized to glargine (205 pts) vs. lispro TID (210 pts) Mean HgbA1c reductions 1.7% glargine 1.9% lispro C.I. ( ) Glargine controlled nocturnal BG better while lispro controlled post-prandial BG better Table in video; for original, see Table 1 in Bretzel RG et al., Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. The Lancet, 2008;371;

9 Choosing an Insulin Regimen: Prandial vs. Basal Insulin APOLLO Trial (Lancet, 2008) Hypoglycemic events were less common with insulin glargine g than lispro (5.2 vs events per year) Mean weight gain was 3.01 kg in glargine and 3.54 in lispro Improvement in treatment satisfaction was greater for insulin glargine Choosing an Insulin Regimen If using prandial insulin. Ametaanalysis meta-analysis of 42 RCTs showed no benefit of rapid acting insulin over regular insulin in managing A1C or in reducing hypoglycemic episodes Plank J, Arch Intern Med 2005 Bottom Line: Choosing an Insulin Regimen Start with a single dose of basal insulin at night Dosing is simple No convincing evidence that another approach offers superior glucose control or safety

10 Combining Insulin with Orals Several meta-analyses have compared the addition of insulin vs. the substitution of insulin to existing oral therapy Addition leads to improved glucose control and reduced insulin dosages Johnson JL. Arch Intern Med 1996 Pugh JA. Diabetes Care 1992 Combining Insulin with Orals Finfat Trial Randomized patients poorly controlled to: insulin + sulf., insulin + metformin, insulin + met. + sulf., insulin bid Followed for 1 year Yki-Jarvinen H. Ann Intern Med 1999 Combining Insulin with Orals Figure in video; for original, see Figure 1 in Yki-Jarvinen H et al., Comparison of Bedtime Insulin Regimens in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Annals of Internal Medicine, 1999;130; Insulin + Metformin: Least weight gain ( kg less) Best glucose control (biggest reduction in A1c) Fewest hypoglycemic events

11 Combining Insulin with Orals: Bottom Line Combining insulin with oral hypoglycemic agents can lead to improved glucose control, decreased weight loss and decreased hypoglycemic events Insulin combined with metformin offers the greatest synergy Evidence to Action: Choosing an Insulin Regimen Start with a single dose of basal insulin at night Dosing is simple No convincing evidence that another approach offers superior glucose control or safety Continue metformin in addition Insulin Dosing and Intensification: Treat-to-Target Start with 10 Units/day of bedtime basal insulin (NPH, glargine, or determir). Adjust insulin every week. To adjust, calculate the mean self-monitored fasting blood glucose values from the previous 2 days. Mean FBG Increase insulin by: mg/dl 2 Units Units Units > Units

12 Insulin Dosing: ADA Guidelines Start with bedtime NPH or long-acting insulin at bedtime or morning. the dosage should be either 10 units or 0.2 units per kg, or higher if hyperglycemia is severe. Fasting glucose should be checked daily Insulin dose increased by 2 units every 3 days if not in the mg/dl range, or by larger increments if glucose is >180. HbA1c should be checked every 2-3 months. If > 7.0, than insulin should be intensified Start with bedtime intermediate-acting insulin or bedtime or morning longacting insulin; can initiate with 10 units or 0.2 units per kg Insulin Titration Check fasting glucose daily and increase dose by 2 units every 3 days until fasting levels are mg/dl; can increase dose more rapidly if fasting glucose >180 A1c >7% after 2-3 months? If hypoglycemia Yes occurs (<70 mg/dl), No reduce bedtime dose If fasting glucose is , check glucose before lunch, dinner, and bedtime. If Continue regimen; check fasting glucose is high, add second basal A1c every 3 months insulin injection Tailor insulin type and dose to findings No A1c >7% after 3 months? Yes Recheck pre-meal glucose levels and if out of range, may need to add another injection; if A1c continues to be out of range, check 2-h postprandial levels and adjust pre-prandial rapid-acting insulin Bottom Line: Insulin Dosing and Intensification Several reasonable approaches any can work Treat-to-Target is easiest but others may be better for particular patients Most important careful, routine followup, monitoring and titration

13 Setting Blood Glucose Goals in the Elderly In frail elderly patients, consider risks of: hypoglycemia, poly-pharmacy, drug interactions American Geriatric Society expert panel recommends: elderly in good health, target A1C < 7% for frail older adults, patients with a life expectancy of less than 5 years, and others for whom risks outweigh the benefits of treatment, a less stringent target (A1C < 8%) is appropriate Putting it all together Start insulin earlier! If A1C > 8.5 on one oral hypoglycemic med Insulin Or if A1C > 8.0 on two oral medications Insulin If A1C is on 2 maximally dosed oral hypoglycemics Consider insulin Tailor glycemic goals in frail elderly patients (A1C goal 8.0) Putting it all together Start with Simple Regimen NPH (at night) is appropriate for most patients Continue metformin or other nonsecretagogue oral hypoglycemics Treat-to-Target and the ADA recommend simple regimens Monitoring and titration are key to achieving blood glucose control

14 Introduction Agenda Session Title Presenter Michael A. Fischer, M.D., M.S. Type 2 Diabetes: diagnosis, definitions, initial management, related conditions Michael A. Fischer, M.D., M.S. The use of oral hypoglycemics in the management of type 2 diabetes Insulin therapy in type 2 DM Niteesh Choudhry, M.D., Ph.D. Michael A. Fischer, M.D., M.S. Academic detailing as a tool to improve care and outcomes in diabetes Jerry Avorn, M.D. From evidence to practice: AHRQ evidence reviews and diabetes management Treatment of diabetes: putting the guidelines into practice Perspectives from a diabetes specialist Michael A. Fischer, M.D., M.S. Niteesh Choudhry, M.D., Ph.D. and Michael A. Fischer, M.D., M.S. Graham McMahon, M.D., M.M.Sc.

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