Efficacy and safety of newer SGLT2 and DPP-IV inhibitors, when given in single pill as combinations versus given as separate pills together, in type 2 diabetes on Metformi
Not Applicable
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/02/049730
- Lead Sponsor
- Jawaharlal Nehru Medical college, Aligarh Muslim University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age >= 18 years
Diagnosis of type 2 diabetes
On metformin dose (>=1000 mg/d)
HbA1c >=8 to 10.0%
Fasting plasma glucose (FPG) <=15 mmol/L (<=270 mg/dl)
Exclusion criteria
Exclusion Criteria
Type 1 diabetic patient and patient on Insulin
Pregnancy, diabetic ketoacidosis
A cardiovascular event in the 3 months before enrolment.
Moderate or severe impairment of renal function (estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c from baselineTimepoint: Mean change in HbA1c from baseline, 12 weeks and 24 weeks
- Secondary Outcome Measures
Name Time Method fasting plasma glucose (FPG)Timepoint: From baseline to week 12 and 24;mean change in systolic and diastolic BPTimepoint: from baseline to week 12 and 24;postprandial blood sugar(PPBS)Timepoint: from baseline to week 12 and 24;The proportion of participants achieving a therapeutic glycemic response HbA1cless than 7.0%Timepoint: at 24 weeks;Total body weightTimepoint: from baseline to week 12 and 24