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The structural changes in Insulin Degludec when compared to Human Insulin are all except

A) Deletion of residue ThrB30

B) Addition of a fatty diacid moiety, hexadecandioyl, attached to LysB29

C) Fatty acid is attached through a Glutamic acid spacer

D) Proline is replaced by Aspartic acid at B28

Mechanism of protraction of Insulin Degludec involves following except

A) Present in the solution as dihexamer(stable)

B) On injection phenol disintegrates leaving the two ends of the dihexamer open which helps in the formation of multihexamers.

C) Insulin degludec is 60% bound to plasma albumin

D) Zinc slowly releases from one end of the multihexamer allowing slow absorption of the monomers into the circulation.

Inclusion criteria for BBT1 includes all of the following except

A) Current treatment with any basal bolus regimen

B) HbA1c ≤10%

c) BMI ≤35Kg/m2

D) Patients with recurrent hypoglycaemia

In BEGIN Phase 3A clinical trial programme, Novo Nordisk definition of Hypoglycaemia includes all the following except

A) Patients with severe hypoglycaemia

B) Patients with measured plasma glucose ≤56mg/dl (3.1mmol/L) with symptoms

C) Patients with measured plasma glucose ≤56mg/dl (3.1mmol/L) without symptoms

D) Patients with measured plasma glucose ≤70mg/dl (3.9mmol/L) with or without symptoms

The draw backs of Phase 3A BEGIN clinical trials according to Owens et al are all the following except

A) Open-label trial design

B) Inclusion of patients with most risk

C) Problems with the analysis of hypoglycaemia

D) Different timing of insulin administration

The trial design for Switch 1 clinical trial is all the following except

A) Double-blind

B) Randomized at 1:1 ratio

C) Treat to Target

D) Placebo controlled

The inclusion criteria for Switch 1 clinical trial is all the following except

A) Age ≥18 years

B) T1D ≥52 weeks

C) Basal–bolus regimen (NPH or IDet OD/BID + 2–4 injections bolus insulin) or CSII ≥26 weeks

D) BMI ≤35 kg/m2

In Switch 1 Study all the following options are correct except

A) Primary end point was treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

B) Data on hypoglycaemic episodes are presented in terms of event rates and percentage of patients with severe hypoglycaemia

C) Severe hypoglycaemia was significantly reduced in the maintainance and full treatment period

D) Patients on Continuous Subcutaneous Insulin Infusion pumps were not included in the study

All the following are the Hypoglycaemia risk inclusion criteria’s for Switch 1 except

A) ≥5 Hypoglycaemic episodes in the past 1 year

B) Moderate chronic renal failure (eGFR 30–59 mL/min/1.73 m2)

C) Diabetes duration for ≥15 years

D) Episode of hypoglycaemia episode within the last 12 weeks (according to ADA definition: ≤70 mg/dL [≤3.9 mmol/L])

The results of Switch 2 clinical trials are all the following except

A) Non-inferiority in the HbA1C is confirmed

B) Significantly lower rate (30%) of severe or BG-confirmed symptomatic hypoglycaemia during the maintenance period

C) Significantly lower rate (42%) of severe or BG-confirmed nocturnal hypoglycaemia during the maintenance period

D) Significantly lower rate (51%) of severe hypoglycaemia during the maintenance period

All the following are correct about the results of Switch 2 clinical trial except

A) 4% significantly lower dose with insulin degludec compared to insulin glargine at the end of 32 weeks

B) First 12 weeks is considered as titration period in both the treatment periods

C) The most frequently reported adverse events in ≥5% patients were nasopharyngitis and upper respiratory tract infection

D) There was no apparent difference between IDeg and IGlar U100 for the standard efficacy parameters or in terms of adverse events

Inclusion criteria for Switch 2 clinical trial are all the following except

A) Age ≥18 years

B) T2D ≥26 weeks

C) Basal insulin + Bolus insulin ± OADs≥26 weeks

D) HbA1c ≤9.5%

Treatment trials regimens for Switch 2 clinical trial are except

A) Once daily administration: Morning or evening

B) Starting dose for patients on OD pre-trial dose is 1:1

C) 20% reduction in the pre-trial dose if the patient was on BD pre-trial regimen

D) After the treatment period 1, the dose initiated was 20% lesser compared to the dose at the end of treatment period 1

FPG target in SWITCH 1 and Switch 2 clinical trial is

A) 71-90mg/dl

B) 80-130mg/dl

c) 80-100mg/dl

D) <140mg/dl

In Switch 1 and Switch 2 studies which of the following is true?

A) Blinding was done by vial and syringes

B) blinding was done by using same devices for same insulin’s

C) Blinding was done by using different devices for different insulin’s

d) Event insulin aspart was also blinded in Switch 1 study

Hypoglycaemia classification in Switch 1 and Switch 2 studies includes all the following except?

A) Severe Hypoglycaemia

B) Symptomatic Hypoglycaemia (Blood Glucose <56mg/dl with symptoms)

C) Asymptomatic Hypoglycaemia (Blood Glucose <56mg/dl without symptoms)

D) Nocturnal hypoglycaemia: events between 00:01 and 05:59

In the article Published by Ghosal et al, for the real world evidence for Tresiba from India, all the following are correct except

A) 27% lesser Insulin dose

B) 70% Lesser hypoglycaemic episodes

C) Significantly more patients achieved glycaemic targets compared to Glargine

D) HbA1C reduction is numerically better with insulin glargine compared to insulin degludec

In the article published by Lena Landstedt-Hallin, for the real world evidence for Tresiba from Sweden, all the following are correct except.

A) 0.3% reduction in HbA1C

B) Dose of insulin is similar

C) 22% reduction in overall hypoglycaemia

D) 56% reduction in nocturnal hypoglycaemia

Following are true with respect to dosing recommendations of Tresiba except

A) Simple initiation with Tresiba with 10U once daily in Type 2 DM patients

B) Switching from existing basal insulin’s is 1:1 transfer to Tresiba in Type 2 DM patients

C) For patients with type 1 diabetes switching to Tresiba from twice-daily basal insulin or with HbA1c<8.0%, individual dosing is required.

D) Titrate daily based on the fasting plasma glucose (FPG measurements)

Which is the following is correct with respect to half-lives of basal insulin’s?

A) NPH: 6.6Hrs

B) Insulin Glargine: 12.1Hrs

C) Insulin Degludec: 25.4Hrs

D) All of the above

According to the meta-analysis by Vora et al, the reduction in dose of insulin with insulin degludec compared to insulin glargine in Type 2 DM patients is?

A) 30%

B) 20%

C) 10%

d) No difference in the dose

In the ONCE LONG trial, there were three times as many patients in the degludec group as in the insulin glargine group(3:1) because

A) more patients preferred insulin degludec

B) more physicians preferred insulin degludec

C) of the need to adequately secure exposure to insulin degludec in accordance with regulatory guidelines

D) one fourth of the enrolled patients had already been treated with insulin glargine

Which is the ongoing long term cardiovascular outcome study for Insulin Delgudec

A) EXAMINE

B) LEADER

C) DEVOTE

d) DUAL

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