NN-Iran/MIP/001/Jan 2010/1

Real life caseReal life case

CASE STUDY: MR. H

Meet Mr. H

Demography Male; aged 55

Height & weight

Height: 167cmWeight: 83 kgBMI: 29.6 kg/m2

Medical history

• Hypertension from 5 years ago, BP = 130/85• Urine microalbumin = 50 μgr /gr Cr• Serum creatinine = 1.7 mg/dl

Family history

• Hypertension in both parents• Type 2 diabetes in his mother

Treatment • Metformin 500 mg BID (1.5 years); Glibenclamide 20 mg/day (8 years)

Glycaemic control

• T2DM diagnosed 10 years ago• Most recent HbA1c: 9.1% (3 months ago)• Past HbA1c: 8.8% six months ago; 7.9% 1 year ago

Meet Mr. H

Day FBG PPG 2-hr Pre Lunch PPG 2-hr Pre eveMeal

Bed Time

(time) (6.30 am) (9 am) (1 pm) (3 pm) (6.30 pm) (11 pm)

1 152 245 127 210 197 152

2 165 284 135 256 201 156

3 174 301 140 289 223 160

What therapeutic adjustments would you consider to improve glycemic control?

Interactive question

• Options:

1. Increasing the dose of OADs / which one? / how much?

2. Adding other OADs / what?

3. Adding Insulin / which type? / why?

4. Others

Case Study: Ms. A

Case 1

• Mrs A. born 1946 / 66 years• Diagnosis of type 2 in 2000• In 1972 there was a suspicion of gestational diabetes• On oral medication until 2006• Then because of HbA1c of 10.1 % and FPG of 14.5

mmol/l (275 mgr/dl) changed to Insulin and metformin

Case 1

• Initially on NPH insulin in the evening• Because of insufficient result changed to self mix

regimen now on 24 U bid 30 % shortacting actrapid and 70 % NPH

• Does not feel very secure with the regimen, fears to make mistakes

• Nocturnal hypo once a month• A lot of problems in the last Ramadan • HbA1c 7.7 % FPG 10.1 mmol/l (192 mgr/dl)

Questions to think on

• How many years delay in the diagnosis was there in 2000 do you think?

• What was the change that you would be able to regulate her in 2006 by putting her on NPH insulin?

• Do you have any idea what her postprandial glucose levels will be now?

Switch

• Make a plan to switch her to Novomix 30 !• Select one of you to present her case

CASE STUDY: MR. B

Case 2

• Mr B, born in 1951 / 61 years• Diagnosis of type 2 in 2004• HbA1c at that time 14.5 %• Retinopathy and microalbiminuria present• Started on NPH insulin, SU and metformin• At the request of the eye specialist changed to self

mix bid after 6 months

Case 2

• SU stopped, metformin continued• Self mix with human shortacting and NPH• Now Breakfast 20/80 24 units• At Dinner 40/60 36 units• Last HbA1c 8.2 %• FPG 9.1 mmol/l (172.9 mgr/dl)• Before dinner 8.3 mmol/l (158 mgr/dl)

Questions to think on

• Was it a wise request from the eye specialist for the change in 2005 ?

• If you did a 7 point curve in this man where would the biggest glycaemic problem be

• He is 61 years old now, has a history of 8 years of diabetes, never in very good control. What should your target for his HbA1c be ?

Switch

• Make a plan to switch him to Novomix 30 !• Select one of you to present her case

Case Study: Ms. C

Case 3

• Mrs C was born in 1932 / 80 years• She was diagnosed around 1990• Treatment in her early years is unclear• From 2000 on she has been on different insulin

regimens in combination with metformin• She now uses a self mix regimen 25/75 in the morning

and 30/70 in the evening

Case 3

• Over the last 6 months she has had several what she calls faints.

• Her daughter complains she is not eating well and has lost 4 kgs in weight

• Her fasting blood glucose values are between 4 and 5.5 mmol/l (76 – 105 mgr/dl)

• We know she has a history of micro- and macro-vascular problems

Questions to think on

• Make a guess at where her HbA1c level will be?• What should be the target for HbA1c in a lady like

this? • What do you want to know about the faints?• What do you think there are?• What could we do to help her?

Switch

• If you switch her to a modern premixed insulin like Novomix 30 how would you do it ?

CASE STUDY: MR. D

Case 4

• Mr D was born in 1966 / 46 years• He has recently been diagnosed as type 2 diabetes

when he was een because of peripheral vascular problems.

• He also has background retinopathy and micro-albuminuria

• Since diagnosis he has been on 2000 mgr of metformin

• His glycaemic control has improved somewhat

Case 4

• HbA1c has come down but remains around 8.4 % now• In your practice you measured a FPG of 7.9 mmol/l

Questions to think about?

• With this glycaemic control what do you think his PPG values will be?

• Make a case for either increasing his oral medication or starting him on insulin now?

• What kind of insulin would you start him on?

Insulin start

• How would you introduce a modern analogue insulin?• Start dose?• Titration?• Who titrates?

NovoMix® 30 - Abbreviated prescribing information

Abbreviated Prescribing Information

NovoMix® 30 (biphasic insulin aspart).

Refer to the Summary of Product Characteristics (SPC) before prescribing.

Presentations: NovoMix® 30 FlexPen®. All presentations contain soluble insulin aspart/ protamine-crystallised insulin aspart 100 units/ml in the ratio of 30/70. Indication: Treatment of diabetes mellitus. Dosage: Individual by subcutaneous injection. NovoMix® 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix® 30 can be given soon after start of a meal. In patients with type 2 diabetes, NovoMix® 30 can be given in monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone. Contraindications: Hypoglycaemia, hypersensitivity to insulin aspart or to any other of the ingredients. Warnings and precautions: Inadequate dosages or discontinuation of treatment may lead to hyperglycaemia and ketoacidosis, which are potentially lethal. A change in the usual early warning symptoms of hypoglycaemia may be seen upon tightening control. The fast onset of action should be considered in patients where a delayed absorption of food might be expected. Transferring to a new type or brand of insulin should be done under strict medical supervision. Too much insulin, omission of a meal or strenuous exercise may lead to hypoglycaemia. Compared with biphasic human insulin, NovoMix® 30 may have a stronger hypoglycaemic effect up to 6 hours after injection. This may need to be compensated for through adjustment of dose and/or food intake. Hypoglycaemia may constitute a risk when driving or operating machinery. Elderly patients: NovoMix® 30 can be used in elderly patients; however there is limited experience with the use of NovoMix® 30 in combination with OADs in patients older than 75 years. Pregnancy and lactation: Limited clinical experience in pregnancy. No restrictions on use during lactation. Side effects: Most of the following undesirable effects are uncommon, rare or very rare. Hypoglycaemia. Oedema, refraction anomalies and local hypersensitivity can occur on instituting therapy and are usually transitory in nature. Acute painful peripheral neuropathy may occur upon fast improvement in blood glucose control but is usually reversible. Generalised hypersensitivity reactions are rare but potentially life-threatening. Lipodystrophy, worsening of diabetic retinopathy. Major drug interactions: Oral Hypoglycemic Agents (OHAs), Monoamine Oxidase Inhibitors (MAOIs) and non-selective beta-adrenergic blocking agents may reduce the patient’s insulin requirements. Oral contraceptives and thyroid hormones may increase the patient’s insulin requirements. Please refer to the patient information leaflet for more information. Prescription only medicine Full prescribing information can be obtained free of charge from Novo Nordisk. IRC number: 1228066993

Abbreviated Prescribing Information

NovoMix® 30 (biphasic insulin aspart).

Refer to the Summary of Product Characteristics (SPC) before prescribing.

Presentations: NovoMix® 30 FlexPen®. All presentations contain soluble insulin aspart/ protamine-crystallised insulin aspart 100 units/ml in the ratio of 30/70. Indication: Treatment of diabetes mellitus. Dosage: Individual by subcutaneous injection. NovoMix® 30 has a faster onset of action than biphasic human insulin and should generally be given immediately before a meal. When necessary, NovoMix® 30 can be given soon after start of a meal. In patients with type 2 diabetes, NovoMix® 30 can be given in monotherapy or in combination with metformin when the blood glucose is inadequately controlled with metformin alone. Contraindications: Hypoglycaemia, hypersensitivity to insulin aspart or to any other of the ingredients. Warnings and precautions: Inadequate dosages or discontinuation of treatment may lead to hyperglycaemia and ketoacidosis, which are potentially lethal. A change in the usual early warning symptoms of hypoglycaemia may be seen upon tightening control. The fast onset of action should be considered in patients where a delayed absorption of food might be expected. Transferring to a new type or brand of insulin should be done under strict medical supervision. Too much insulin, omission of a meal or strenuous exercise may lead to hypoglycaemia. Compared with biphasic human insulin, NovoMix® 30 may have a stronger hypoglycaemic effect up to 6 hours after injection. This may need to be compensated for through adjustment of dose and/or food intake. Hypoglycaemia may constitute a risk when driving or operating machinery. Elderly patients: NovoMix® 30 can be used in elderly patients; however there is limited experience with the use of NovoMix® 30 in combination with OADs in patients older than 75 years. Pregnancy and lactation: Limited clinical experience in pregnancy. No restrictions on use during lactation. Side effects: Most of the following undesirable effects are uncommon, rare or very rare. Hypoglycaemia. Oedema, refraction anomalies and local hypersensitivity can occur on instituting therapy and are usually transitory in nature. Acute painful peripheral neuropathy may occur upon fast improvement in blood glucose control but is usually reversible. Generalised hypersensitivity reactions are rare but potentially life-threatening. Lipodystrophy, worsening of diabetic retinopathy. Major drug interactions: Oral Hypoglycemic Agents (OHAs), Monoamine Oxidase Inhibitors (MAOIs) and non-selective beta-adrenergic blocking agents may reduce the patient’s insulin requirements. Oral contraceptives and thyroid hormones may increase the patient’s insulin requirements. Please refer to the patient information leaflet for more information. Prescription only medicine Full prescribing information can be obtained free of charge from Novo Nordisk. IRC number: 1228066993

Novo Nordisk ParsNovo Nordisk Pars1111thth floor, Kian Tower floor, Kian TowerNo. 1387, Vali-e-Asr Ave.No. 1387, Vali-e-Asr Ave.TehranTehranIranIran

NN-Iran/MIP/001/Jan 2010/1