Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326034
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2024-03-16
Brief Title:
Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients
Sponsor:
Mohammed Mahmood Mohammed
Organization:
Al-Mustansiriyah University
Study Overview
Official Title:
Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients physical and psychological status and thus lower the patients quality of life QoL Verma Dadarwal 2017Vanstone et al 2015Gebremedhin et al 2019 According to American Diabetes Association ADA when hyperglycaemia remain uncontrolled HbA1c 15 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 2014Inzucchi 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 2007Sazan 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 2010Najim et al 2014Fonseca 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 2020Solomon et al 2022Wiviott et al 2019McMurray 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
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 2014Inzucchi 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 2007Sazan 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 2010Najim et al 2014Fonseca 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 2020Solomon et al 2022Wiviott et al 2019McMurray 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
Detailed Description:
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 7-120 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
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 7-120 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None