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.
The aim of this prospective observational study is to evaluate the effect of Dapagliflozin oral tablets in reduction HbA1C and body weight after 6 months in Type II Diabetes Mellitus Patients.
Design
Single arm, Open Label, Post Marketing Interventional Trial
Settings and conduct
Medicine Department of Bahawal Victoria Hospital, Bahawalpur. and Diabetes department of Laiq Rafique Foundation, Multan.
Patients meeting the eligibility criteria will be included after written informed consent. The decision to start treatment will be made by the Investigators as per clinical practice. Planned no. of patients for this specific study is n=400. Patients will be prescribed Dapagliflozin as per physician discretion. Planned study duration is 24 weeks for a single patient. Through HbA1C, body weight determination patients’ response to therapy would be gauged. Patients' follow-up visits would be at Week 02, 04, 12 & 24.
Participants/Inclusion and exclusion 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:
• 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.
Intervention groups
Intervention group: Dapagliflozin 5 or 10 mg as Per Investigator Discretion
Main outcome variables
1. Reduction in HbA1c from baseline observed at week 12 and 24 after initiation of therapy.
2. Reduction in Body weight from baseline observed at week 2, 4, 12 & 24 after initiation of therapy.
General information
Reason for update
Acronym
DEFINED
IRCT registration information
IRCT registration number:IRCT20170614034526N5
Registration date:2019-10-09, 1398/07/17
Registration timing:retrospective
Last update:2019-10-09, 1398/07/17
Update count:0
Registration date
2019-10-09, 1398/07/17
Registrant information
Name
Dr. Sharib Syed Muhammad
Name of organization / entity
Hilton Pharma Pvt Ltd
Country
Pakistan
Phone
(021) 111-123-000 Ext:428
Email address
sharibsyed@hiltonpharma.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-03, 1397/09/12
Expected recruitment end date
2019-03-31, 1398/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Dapagliflozin Efficacy & Safety as Mono or Combination therapy in reduction of HbA1C and Body Weight in Type II Diabetes Mellitus Patients.
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board, Quaid e Azam Medical College Bahawalpur
Street address
Bahawalpur Cantt, Bahawalpur,
City
Bahawalpur
Postal code
63100
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
470/DME/QAMC
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Type 2 Diabetes mellitus
Primary outcomes
1
Description
Reduction in HbA1c
Timepoint
measured at week 12 & week 24.
Method of measurement
Hba1C test.
2
Description
Body Weight Reduction
Timepoint
week 02, 04, 12 & week 24
Method of measurement
Physical Measurement
Secondary outcomes
1
Description
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
Intervention groups
1
Description
Intervention group: Dapagliflozin 5 or 10 mg as Per Investigator Discretion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medicine Department, Quaid-e-Azam Medical College,