Case Study Hands On Experience Patient case study

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Case Study Hands On Experience

Case Study Hands On Experience

Patient case study: Patient A Patient information Age, gender • 55 years old, male

Patient case study: Patient A Patient information Age, gender • 55 years old, male Duration • Type 2 diabetes for 10 years Current treatment • • Metformin (1000 mg BID) Gliclazide (80 mg before breakfast and dinner) Rosuvastatin (10 mg daily) ASA (80 mg/d. L) Current Lab. • • Hb. A 1 c: 9. 2% FPG: 205 mg/d. L PPG: 216 mg/d. L Cr: 0. 8 mg/d. L BP - BMI • 135/85 mm. Hg - 26 kg/m 2 Additional background • No diabetic complications • Employee; dinner is the main meal • • TG: 200 mg/d. L LDL: 87 mg/d. L ALT: 24 IU/L U/A: +1 Glucose

Mr A: 7 -points curve Fasting 205 Post breakfast Pre Lunch Post lunch Pre

Mr A: 7 -points curve Fasting 205 Post breakfast Pre Lunch Post lunch Pre dinner After dinner 3 am Hb. A 1 c 216 125 187 142 312 242 9. 2%

Options & Comments: 1) Metformin/Gliclazide? 2) Adding / replace Repaglinide? 3) Adding Acarbose? 4)

Options & Comments: 1) Metformin/Gliclazide? 2) Adding / replace Repaglinide? 3) Adding Acarbose? 4) Adding Pioglitazone? 5) Adding basal Insulin? 6) Adding prandial Insulin? 7) Starting pre-mixed Insulin? 8) Starting basal/prandial Insulin Analogues?

Presentation title Date 6

Presentation title Date 6

Presentation title add? • Injection treatment • Basal insulin or premix • victosa •

Presentation title add? • Injection treatment • Basal insulin or premix • victosa • Oral drugs Date 8

Treatment of Mr A Started with Novomix® Before Dinner

Treatment of Mr A Started with Novomix® Before Dinner

After taking Novomix® for one week, SMBG of A • Fasting 180 mg/dl Titrated

After taking Novomix® for one week, SMBG of A • Fasting 180 mg/dl Titrated the dose during 3 months 12 units 14 units 16 units

Lab. Results: • Hb. A 1 c Reduction (3 m. later) 9. 2% -1.

Lab. Results: • Hb. A 1 c Reduction (3 m. later) 9. 2% -1. 9 % 7. 3%

Lab. Results: (2 m. later) • Fasting plasma glucose Reduction 205 mg/d. L -85

Lab. Results: (2 m. later) • Fasting plasma glucose Reduction 205 mg/d. L -85 mg/d. L 120 mg/d. L

Mr A: 7 -points curve Fasting 120 Post breakfast Pre Lunch Post lunch Pre

Mr A: 7 -points curve Fasting 120 Post breakfast Pre Lunch Post lunch Pre dinner 122 After dinner Hb. A 1 c 7. 3%

14 Glycemic targets American Diabetes Association. Diabetes Care 2016.

14 Glycemic targets American Diabetes Association. Diabetes Care 2016.

Clinical challenge: Hb. A 1 c reduction (%) Selecting the appropriate treatment for your

Clinical challenge: Hb. A 1 c reduction (%) Selecting the appropriate treatment for your patient 0. 0 0. 5 1. 0 1. 5 2. 0 2. 5 3. 0 Sulfonylureas Metformi n Glinides DPP-IV inhibitors 0. 5 -0. 7 1. 5 Efficacy as mono therapy 1. 5 1. 01. 5 GLP-1 RAs TZDs 1. 0 -1. 5 0. 5 - 0. 8 Insulin ≥ 2. 5 Insulin is the most effective glucose-lowering agent Nathan DM. N Engl J Med. 2007; 356: 437 -40 Nathan et al. Diabetes Care. 2009; 32: 193 -203 Anti diabetic agents

IDF treatment algorithm (2013 update) Lifestyle measures Usual approach Alternative approach Then, at each

IDF treatment algorithm (2013 update) Lifestyle measures Usual approach Alternative approach Then, at each step, if not to target (generally Hb. A 1 C<7. 0%) Consider first line Sulfonylurea or α-glucosidase Metformin Consider second line Sulfonylurea Metformin (if not first line) or α-gluc or DPP-4 or TZD or GLP-1 agonist Consider third line Basal insulin or pre-mix insulin or Consider fourth line Basal + mealtime insulin Basal or pre-mix (later basal+mealtime) IDF 2012 Global Guidelines for Type 2 diabetes

Presentation title Date 18

Presentation title Date 18

Patient case study: Patient B Patient information Age, gender • 48 years old, female

Patient case study: Patient B Patient information Age, gender • 48 years old, female Duration • Type 2 diabetes for 8 years Current treatment • • Metformin (1000 mg BID) Gliclazide (160 mg before breakfast and dinner) Atorvastatin (20 mg daily) Losartan (25 mg daily) Current Lab. • • Hb. A 1 c: 9. 6% FPG: 195 mg/d. L PPG: 255 mg/d. L Cr: 1 mg/d. L BP - BMI • 140/80 mm. Hg - 25. 8 kg/m 2 Risk factors & complications • Hypertension • Non- proliferative Retinopathy Additional background • Doesn’t exercise • Bank employee; 2 main meals (8 am, 8 pm) and snacks • • TG: 250 mg/d. L LDL: 77 mg/d. L ALT: 12 IU/L U/A: +2 glucose

Mrs B: 7 -point curve Fasting Post breakfast Pre Lunch Post lunch Pre dinner

Mrs B: 7 -point curve Fasting Post breakfast Pre Lunch Post lunch Pre dinner After dinner Hb. A 1 c 195 255 220 245 196 296 9. 4%

Options & Comments: 1) Metformin/Gliclazide? 2) Adding/replace Repaglinide? 3) Adding Acarbose? 4) Adding Pioglitazone?

Options & Comments: 1) Metformin/Gliclazide? 2) Adding/replace Repaglinide? 3) Adding Acarbose? 4) Adding Pioglitazone? 5) Adding Sitagliptin? 6) Adding basal Insulin? 7) Adding prandial Insulin? 8) Starting pre-mixed Insulin? 9) Starting basal/prandial Insulin?

Benefits of long-term insulin use : risk of CV maladies • Insulin reduces cardiovascular

Benefits of long-term insulin use : risk of CV maladies • Insulin reduces cardiovascular risk from diabetes 1 50% of patients with T 2 DM with complications already have them at diagnosis 2 -14% risk Each Hb. A 1 c percentage point reduction counts 3 -37% Micro-vascular complications -21% risk Death related to diabetes risk Hb. A 1 c -1% 1. 2. 3. Non-fatal Myocardial infarction Holman, et al. NEJM 2008; 359: 1577– 89 UKPDS 6. Diabetes Res 1990; 13(1): 1 -11 Stratton, et al. BMJ 2000; 321(7258): 405 -12

Improved PPG after switching to BIAsp 30 from BHI Efficacy PRESENT subgroup analysis Hb.

Improved PPG after switching to BIAsp 30 from BHI Efficacy PRESENT subgroup analysis Hb. A 1 c 1. 58% FPG PPG 53 mg/d. L Shestakova et al. CMRO 2007; 23(12): 3209 -3214 85. 5 mg/d. L

Improved PPG reduction on BIAsp 30 vs. human premix IMPROVE subgroup analysis PPG (mg/d.

Improved PPG reduction on BIAsp 30 vs. human premix IMPROVE subgroup analysis PPG (mg/d. L) -99* -93* -58* Baseline Final * p<0. 001 Cohort includes patients switching from BHI 30 to BIAsp 30 for 24 weeks Shah et al. Int J Clin Pract 2009; 63(4): 574 -582

Premix insulin titration strategy INITIATE study titration algorithm Titration based on the lowest SMPG

Premix insulin titration strategy INITIATE study titration algorithm Titration based on the lowest SMPG value on any 3 days prior to titration Pre-prandial blood glucose value Premix insulin dose adjustment mmol/L mg/d. L Units < 4. 4 < 80 -2 4. 4 -6. 1 80 -110 No adjustment 6. 2 -7. 8 111 -140 +2 >7. 8 >140 +4 Any episodes of hypoglycaemia should be taken into account prior to titration Unnikrishnan et al. IJCP 2009: 63(11): 1571 -7

Patient case study: Patient C Patient information Age, gender • 65 years old, female

Patient case study: Patient C Patient information Age, gender • 65 years old, female Duration • Type 2 diabetes for 10 years Current treatment • • • Metformin (1500 mg /day) Gliclazide (80 mg before breakfast and dinner) Sitagliptin (100 mg/day) Atorvastatin (10 mg daily) Losartan (12. 5 mg daily) Current Lab. • • Hb. A 1 c: 10% FPG: 220 mg/d. L PPG: 300 mg/d. L Cr: 0. 9 mg/d. L BP - BMI • 130/80 mm. Hg - 24 kg/m 2 Risk factors & complications • Hypertension • Non- proliferative Retinopathy Additional background • Doesn’t exercise • 3 meals and 2 snacks • • TG: 265 mg/d. L LDL: 80 mg/d. L ALT: 30 IU/L U/A: +3 glucose

Mrs C: 7 -point curve Fasting Post breakfast Pre Lunch Post lunch Pre dinner

Mrs C: 7 -point curve Fasting Post breakfast Pre Lunch Post lunch Pre dinner After dinner Hb. A 1 c 220 300 250 220 320 10%

Options & Comments: 1) Metformin/Gliclazide? 2) Adding/replace Repaglinide? 3) Adding Acarbose? 4) Adding Pioglitazone?

Options & Comments: 1) Metformin/Gliclazide? 2) Adding/replace Repaglinide? 3) Adding Acarbose? 4) Adding Pioglitazone? 5) Adding basal Insulin? 6) Adding prandial Insulin? 7) Starting pre-mixed Insulin? 8) Starting basal/prandial Insulin?

Presentation title Start: • Basal and bolus insulin • Basal insulin alone • Premixe

Presentation title Start: • Basal and bolus insulin • Basal insulin alone • Premixe insulin Date 37

Mean Hb. A 1 c at last visit (%) Insulin use is often delayed,

Mean Hb. A 1 c at last visit (%) Insulin use is often delayed, despite poor glycaemic control 10 9. 4% 8. 8% 9 8 n i l u s n I Diet 2. 9 years OAD, oral antidiabetic drug Roper Starch US Study, 2000. 9. 1% a i t r ne 3 OADs I n tio 2 OADs a i t i I 1 n. OAD 4. 7 years 2. 5 years 2. 7 years

The 1 -2 -3 Study Safety Efficacy Hb. A 1 c <7% (ADA goal)

The 1 -2 -3 Study Safety Efficacy Hb. A 1 c <7% (ADA goal) Once Daily 41% Twice Daily 70% Three Times Daily 77% Phase 1 OD Phase 2 BID Phase 3 TID 3 3 1 Rate of minor hypoglycaemic episodes 15 22 12 Major nocturnal hypoglycaemia episodes 0 0 0 Number of patients with major hypoglycaemic events Garber A, et al. Diabetes, Obesity and Metabolism 2006; 8(1): 58 -66

Presentation title • Thank you Date 48

Presentation title • Thank you Date 48

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI:

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI: 10. 2337/dc 16 -S 010

Basal Insulin Overtreatment Anthony L. Mc. Call. Endocrinol Metab Clin N Am 2012; 41:

Basal Insulin Overtreatment Anthony L. Mc. Call. Endocrinol Metab Clin N Am 2012; 41: 57– 87.

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI:

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI: 10. 2337/dc 16 -S 010

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI:

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI: 10. 2337/dc 16 -S 010

Intensifying With Novo. Mix® 30 BIAsp, biphasic insulin aspart; BID, twice daily; OD, once

Intensifying With Novo. Mix® 30 BIAsp, biphasic insulin aspart; BID, twice daily; OD, once daily; TID, three-times daily; TZDs, thiazolidinediones Unnikrishnan et al. Int J Clin Pract 2009; 63: 1571– 7

BIAsp® 30: dosage regimen Timing of blood glucose measurements used for dose titration Dose

BIAsp® 30: dosage regimen Timing of blood glucose measurements used for dose titration Dose to titrate BIAsp 30 OD BIAsp 30 BID BIAsp 30 TID Breakfast – Pre-dinner Pre-lunch Lunch – – Pre-dinner Dinner Pre-breakfast BIAsp, biphasic insulin aspart; BID, twice daily; OD, once daily; TID, three-times daily Garber et al. Diabetes Obes Metab 2006; 8: 58– 66; Raskin et al. Diabetes Care 2005; 28: 260– 5

Titration Guide Unnikrishnan et al. Int J Clin Pract 2009; 63: 1571– 7

Titration Guide Unnikrishnan et al. Int J Clin Pract 2009; 63: 1571– 7

Patient case study: Patient information Age, gender • 61 years old, male Duration •

Patient case study: Patient information Age, gender • 61 years old, male Duration • Type 2 diabetes for 20 years Current treatment • Lansulin 70/30 (25 -20 -15) • Cell sept ( 1 g Bid) • Atorvastatin (20 mg daily) Current Lab. • Hb. A 1 c: 9. 7% • FPG: 223 mg/d. L • PPG: 300 mg/d BP – Wt - BMI • 140/80 mm. Hg - 72 kg - 25. 8 kg/m 2 Additional background • 20 yrs HTN/ PCI: 10 yrs ago/ PDR: laser+ • Renal transplant: 4 yrs ago living donor • Prednisolon (2. 5 mg daily) • ASA (80 mg/day) • Atenolol (100 mg daily) • Cr: 1. 1 mg/d. L • TG: 220 mg/d. L • LDL: 82 mg/d. L

Options & Comments: 1) Adding Metformin? 2) Adding Gliclazide/Repaglinide? 3) Adding Acarbose? 30 :

Options & Comments: 1) Adding Metformin? 2) Adding Gliclazide/Repaglinide? 3) Adding Acarbose? 30 : 22 Pioglitazone? IU breakfast – 22 IU lunch – 22 IU dinner 4)Novomix Adding Lansulin D/C

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI:

Intensification of insulin regimens Diabetes Care 2017; 40(Suppl. 1): S 64–S 74 | DOI: 10. 2337/dc 16 -S 010

Patient case study: 29/6/89 Patient information ( ﻓﺎﻃﻤی. . . )ﻗﺪﺭﺕ ﺍ Age, gender

Patient case study: 29/6/89 Patient information ( ﻓﺎﻃﻤی. . . )ﻗﺪﺭﺕ ﺍ Age, gender • 69 years old, male Duration • Type 2 diabetes for 10 years Current treatment • Metformin (1000 mg/day) • Glibencalmide (20 mg/day) Current Lab. SMBG • FPG: 250 – 400 • BS: 400 - 500 BP • 160/70 mm. Hg He admitted for insulin therapy

Mr G. F – 29/7/1389 BP: 120/70 mm. Hg/ Eye Exam: mild NPDR •

Mr G. F – 29/7/1389 BP: 120/70 mm. Hg/ Eye Exam: mild NPDR • Metformin 1500 mg/day • Insulin NPH 18 IU (am) – 4 IU (pm) • Insulin Regular 10 IU (am) – 4 IU (pm)

Recent Follow Ups

Recent Follow Ups

Presentation title Date 63

Presentation title Date 63

Mr G. F – 11/12/1394 BP: 130/80 mm. Hg/ Wt: 71 kg/ Variable BS

Mr G. F – 11/12/1394 BP: 130/80 mm. Hg/ Wt: 71 kg/ Variable BS with frequent hypos • Metformin 1000 mg Bid • Insulin NPH 16 IU (am) – 10 IU (pm) • Insulin Regular 18 IU (am) – 10 IU (pm) • Atorvastatin 20 mg Qd • Losartan 50 mg Bid • Hydrochlorothiazide 50 mg Qd • ASA 80 mg Qd • Gabapentin 300 mg Qhs

What is your recommendation?

What is your recommendation?