Dapagliflozin Efficacy & Safety as Mono or Combination therapy in reduction of HbA1C and Body Weight in Type II Diabetes Mellitus Patients.

Prospective Efficacy & Safety study of Monotherapy or Combination therapy with Dapagliflozin in reduction of HbA1C and Body Weight in newly diagnosed or treatment experienced Type II Diabetes Mellitus Patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170614034526N5

Enrollment

400

Registered

2019-10-09

Start date

2018-12-03

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus. Type 2 Diabetes mellitus

Interventions

Intervention group: Dapagliflozin 5 or 10 mg as Per Investigator Discretion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male & Female (Non-pregnant) Patients = 18 years of age with type II Diabetes Mellitus. Type II diabetes mellitus patients having controlled diabetes HbA1C 7-10 % or uncontrolled diabetes (HbA1C 10-12%). Patients having BMI of > 25 kg/m2. Not Hypersensitive to Dapagliflozin or any of ingredients.

Exclusion criteria

Exclusion criteria: Male & Female Type I Diabetes patients. Patients having complaints of urinary tract infections, genital infections Patients with e GFR < 60 mL/min/1.73 m². Pregnant Females. Patients with end stage renal disease, or going through dialysis. Suspected Ketoacidosis patients.

Design outcomes

Primary

Measure	Time frame
Reduction in HbA1c. Timepoint: measured at week 12 & week 24. Method of measurement: Hba1C test.;Body Weight Reduction. Timepoint: week 02, 04, 12 & week 24. Method of measurement: Physical Measurement.	—

Secondary

Measure	Time frame
Serious adverse events (SAE) and non-serious adverse events will be observed. An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the procedure. Timepoint: At Week 04, 12 & 24. Method of measurement: Clinical Examination.	—

Countries

Pakistan

Contacts

Public ContactProf. Dr. Qazi Masroor

Medicine Department, Quaid-e-Azam Medical College,

masroorqazi@outlook.com+92 62 2731042

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026