Clinical Trial Summary
Type 2 Diabetes Mellitus (T2DM) is a syndrome of metabolic dysregulation that needs a
multifactorial behavioral and pharmacological treatments to prevent or delay complications,
morbidity and mortality. Uncontrolled hyperglycemia can be negatively affecting the patient's
physical and psychological status and thus lower the patient's quality of life (QoL) (Verma &
Dadarwal, 2017)(Vanstone et al., 2015)(Gebremedhin et al., 2019). According to American
Diabetes Association (ADA), when hyperglycaemia remain uncontrolled (HbA1c ≥1.5% above the
glycemic target), a second therapy for T2DM is needed (Davies et al., 2022).
It has been certained by ADA, beside the glucose lowering effect the add-on antidibetic
medication should have an impact on weight management to achieve and maintain the optimum
glycemic and weight control which are the goals in people without established cardiorenal
risks (Vijan et al., 2014((Inzucchi et al., 2012). Although metformin still the first-line
pharmacotherapy in most T2DM patients, according to American Diabetes Association (ADA)
(Association, 2020) but has little or even weight neutral effect, as well as gliptins
(Hermansen & Mortensen, 2007)(Sazan et al., 2012). Other old antidibetic classes such as
thiazolidinediones (TZDs) and sulfonylureas (SUs) inspite of their efficacy in controlling
glycemia but their use is associated with weight gain and other adverse effects (Derosa &
Maffioli, 2010)(Najim et al., 2014)(Fonseca, 2003). However, The newest class of antidibetic
drugs, sodium-glucose cotransporter 2 inhibitors (SGLT2i), are approved for the treatment of
T2DM as add-on or even initial therapy (Tamez-Pérez et al., 2013). This class is act by
inducing glycosuria and thus improving glycemic status without affecting insulin level
(Merovci et al., 2015). Dapagliflozin is a highly selective inhibitor of SGLT2. It has been
well tolerated and its safety and efficacy approved in the clinical trials, mostly on
cardio-renal outcomes with additional benefits of weight loss and low risk of hypoglycemia
(Heerspink et al., 2020)(Solomon et al., 2022)(Wiviott et al., 2019)(McMurray et al., 2019).
To date, no clinical data regarding SGLT2i recorded in Iraqi patients with limited data
available on Arabic population. On Qatari, assessment of Dapagliflozin effectiveness revealed
a significant improvement in the glycemic status after 6 months when used in combination with
standard therapy, a reduction (Al AdAwi et al., 2019). In Saudi Arabia, Dapagliflozin was
found to be well-tolerated and effective treatment option for T2DM patients after 6 months
(Alguwaihes, 2021).
This interventional randomized clinical study was conducted from May to December 2022, at the
National Diabetic Centre for treatment and research/ Mustansiriyah University/ Baghdad/ Iraq.
Ethical approval from the diabetic center and college of pharmacy/ Mustansiriyah University,
was taken prior to the study initiation. All investigations/ procedures carried out in this
study involving human participants were in accordance with the 1975 Declaration of Helsinki
and its later amendments.
Participants Recruitment Patients enrolled in the study with the following criteria: T2DM
patients, age between 18-70 years, on a combination of OADs (sulfonylurea + metformin +
gliptin) for at least 8 weeks before enrolment. Patients involved had an elevated
glycosylated hemoglobin A1c (HbA1c) [7%-12.0%] at the time of enrollment. Patients who met
the inclusion criteria and agreed to the study protocol were recruited, a written consent was
obtained from all participants before starting the study. All patients involved were received
Dapagliflozin 5mg once daily for 16 weeks. Sulfonylurea could be down-titrated only once
during the treatment period to mitigate the risk of recurrent hypoglycemic events at the
discretion of the investigator. Initially, 45 participant who met the criteria involved in
the study and finished all the baseline requirement. At the end of the study, five cases
recruited and the most with the commonest reasons for discontinuation being non-adherent with
the study medication (1 case), non-compliance with the appointment (2 cases) and adverse
events (2 cases of genitourinary infection). A total of 40 patients were completed the study.
