Dear Dr. {{$doctorName}}
Subject: Participation
in study “Evaluation of drug utilization pattern of Voglibose
and
its combinations in type 2 Diabetes Mellitus patients
(V-FIT-II)”
Type 2 Diabetes Mellitus
(T2DM) is a complex chronic disease which requires multiple
pharmacological interventions to control glucose level and prevent
further complications.
Diabetes is a major risk factor for cardiovascular disease (CVD).
Patients with type 2
diabetes have a 2–4 times higher risk of CVD mortality than those
without diabetes
India is
home to 74.2 million diabetic individuals, the burden of diabetes in
India is of
epidemic proportions. Indians have high genetic predisposition, high
susceptibility to
environmental insults, and early onset of the disease. In India, we
see largely diverse life
style, food pattern and activities, with diet pattern traditionally
having a high glycemic
index. Carbohydrates constitute 64.1% of total energy from diet in
T2DM participants,
higher than that recommended in Indians
Postprandial Hyperglycemia (PPH) contributes over 50 % to HbA1c at
A1C
< 8.4 %. PPH is often seen in individuals with an apparently good
glycemic control (HbA1c <7%) & average fasting glucose levels
within recommended goals (</=120mg/dl). The outcomes from
Chicago HEART Association study, DECODE, and Diabetes
Intervention study have clearly stated that post meal glucose
surge has increased mortality and cardiovascular complications
in patients with Diabetes Mellitus.
Voglibose, a ɑ-glucosidase inhibitor, controls PPG level and
has
cardiovascular benefits.
Its systemic absorption is negligible hence it is ideal for
elderly and those with hepatic
complications. Despite its accepted benefits & efficacy, the
usage of Voglibose in routine
clinical practice remains undetermined.
Real-world evidence on management of post prandial
hyperglycemia
can help bridge the
evidence gap by providing better insights for drug
utilization
patterns of Voglibose, drug
adherence, comorbidities, and effects of switching or
adjusting
medications in the real
world. Currently, there is limited evidence on utilization
pattern of Voglibose. This study
is planned to evaluate drug utilization pattern of voglibose
and
the prevalence of post
prandial hyperglycemia in T2DM patients in India.
We
invite you to participate in this study. On acceptance, you
will
need to capture the
relevant data as mentioned in the standard Data Collection
Form
(DCF) provided, from
the patient’s medical records (case papers and
investigational
reports – hereafter referred
as source documents).
We
would recommend you to capture data fulfilling the criteria
as
outlined in the protocol
and whose relevant laboratory investigations are available
for
the preceding 3 months.
We wish to inform you that the DCF will capture all data in
de-identified form and any
identifiable parameters which may potentially disclose the
identity of the patient such as
name or address will strictly not be captured so as to
ensure we
maintain patient
confidentiality. We would encourage you to carefully fill
all
available information to the
fullest as recommended in the DCF.
In
alignment with good clinical research practices, an
independent
CRO will monitor this
study and do the source data verification of the data
captured
in the DCF with copies of
the patients’ source medical records (case papers and
investigational reports) to ensure
that the data entered in the DCFs are accurate and in
alignment
with the patients’ medical
records.
If
you agree to participate in the said study, we would request
you
to sign and return the
enclosed reply along with your visiting card for accuracy of
records.
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