VILDAGLIPTIN The VERIFY ildagliptin Efficacy in combination ... · Vildagliptin Efficacy in...

Vildagliptin Efficacy in combination with metfoRmIn For earlY treatment of type 2 diabetes

TheVERIFYSTUDY

TheVERIFYSTUDY

Methods

Randomised,double-blind,

parallel-groupstudy

Newly diagnoseddrug naive T2DM

patients withHbA1c 6.5-7.5%

across254

centres

across163 IndianPatients

34countries

13Indian

centres

Basal Insulin

Basal Insulin

Metformin up to 1000 mgtwice daily plus vildagliptin

50 mg twice daily

Metformin up to 1000 mgtwice daily plus vildagliptin

50 mg twice daily

500 mgper day

1000 mgper day

1500 mgper dayStudy

Inititation

3 Week MetforminRun-in Period

2 Week ScreeningVisit

Metformin up to 1000 mgtwice daily plus vildagliptin

50 mg twice daily

Metformin up to 1000 mgtwice daily plus placebo

50 mg twice daily

HbA1c > 53 mmol/mol (7.0%)twice, 13 weeks apart

Period 1 Period 2 Period 3

Time to initialtreatment failure

Time to secondtreatment failure

At Investigatordiscretion

Rand

omis

atio

n

Results

Initiating therapy with Vildagliptin Metformin combination provides greater and durable glycemic control compared to metformin alone

Conclusion

METFORMIN

VILDAGLIPTIN

METFORMIN

Early intervention with a combination therapyof vildagliptin plus metformin

current standard-of-careinitial metformin monotherapy

First studyto invesigate the long-term clinical benefits ofearly (HbA1c - 6.5-7.5%) dual combination treatmentversus standard-of-care metformin monotherapy

Vildagliptin ENHANCEDGLYCAEMICDURABILITY

Metformin

Relative risk reduction in time to treatment failure** withinitial combination of vildagliptin/ metformin vs sequential#combination of vildagliptin/metformin

Low risk of hypoglycemia and mild body weight reduction

in both the groups

Relative risk reduction for time-to-initial treatment failure withvildagliptin/metformin combination vs metformin alone

49%*

Additional glycemic durability with vildagliptin/metformin

combination vs metformin alone

>2Years1

26%

Referrence:Matthews DR et al. Lancet. 2019;394:1519-29.*In early T2DM patients with mild hyperglycaemia (HbA1c 6.5 - 7.5%), vildagliptin/metformin combination reduced the risk of time toinitial treatment failure by 49% {HR 0.51 (95% CI 0.45-0.58); p<0.0001)} vs. metformin alone HR: Hazard Ratio CI:Confidence Interval@ In early T2DM patients with mild hyperglycaemia (HbA1c 6.5 – 7.5%), initial combination with metformin/vildagliptincombination reduced the risk of time to second treatment failure by 26% {HR 0.74 (95% CI 0.63-0.86); p<0.0001} vs.sequential addition of metformin/vildagliptin#Sequential combination: Addition of second drug after treatment failure i.e. crossing HbA1c ≥ 7% twice**Time to treatment failure was defined as exceeding HbA1c ≥ 7% twice