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
Top Related