Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients

NCT06326034 | Completed Phase 4 DMC

• 1 other identifier: AAA234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (1)

• Quality of Life Assessment tool

  The QOLSID tool, introduced in 2020 by Mikhael EM et al. (Mikhael et al., 2020), was used in this study to measure the QoL in T2DM. The questionnaire consisted of 10 questions with 5 likert scale answers ranging from (0-4). Scores more than 32.5 indicates a good quality of life.

  the QOLSID was administered to the participants at study initiation (week 0) and after 16 weeks of study initiation.

Study Arms (1)

Dapagliflozin group

EXPERIMENTAL

The study's outcomes measured the changes pre- and post-treatment with Dapagliflozin (week 0 to weeks 16). The following parameters being measured: HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG; glucose level measured 2 hours after standardized breakfast), body weight (BW), height (Ht), waist circumference (WC), body mass index (BMI), index of central obesity (ICO), and patients' QoL.

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Dapagliflozin 5 mg orally given once daily for four months.

Dapagliflozin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elevated glycosylated hemoglobin A1c (HbA1c) \[7%-12.0%\] at the time of enrollment

Sponsors & Collaborators

• Mohammed Mahmood Mohammed: lead

Study Sites (1)

Mohammed Mahmood Mahmood

Baghdad, 00964, Iraq

Location

MeSH Terms

Interventions

dapagliflozin

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mohammed Mahmood Mohammed

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: May 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)