Comparative study of efficacy, safety and patient compliance of Dapagliflozin and Metformin Vs Vildagliptin and Metformin combination therapy in newly diagnosed Type 2 diabetes patients
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change in HbA1C level after 24 weeks of treatment.
Study Overview
Brief Summary
Diabetes is one of the most common chronic and non communicable disease with more than 350 million cases wordwide. The disease burden contributed by India is steadily increasing from 26 million in 1990 to 65 million in 2016. The age standardized disease prevalence has increased by 39.6% during the same period. The treatment of the disease is costly and type 2 diabetes (T2DM) constitutes for approximately 90% of the disease burdeManagement of the disease is multimodal and focuses on lifestyle management, diabetes self management education and specific medication. For newly diagnosed T2DM patients choosing the appropriate drug or drug combination is crucial in achieving the goal of preventing or delaying complications and maintaining as well as improving quality of life.The management strategy must be specific, measurable, achievable, realistic and time limited.4 Choice of drugs for the treatment should be individualized taking in to consideration of the factors like HbA1c, body weight, hypoglycaemia, side effects, cost and convenience.4
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Newly diagnosed T2DM patients with or without metformin therapy 2)HbA1C ≥7.5 3)Age 18-75 yrs.
Exclusion Criteria
- •Type 1DM, Patient taking metformin 1000mg/day with poor glycemic control 2)eGFR <45 ml/min/1.73m2 3)CHF 4)Pregnancy 5)Lactation 6)Patients with Child bearing potential 7)Active Malignancy 8)Chronic inflammatory disorders 9)Chronic alcoholism 10)History of pancreatitis.
Outcomes
Primary Outcomes
Change in HbA1C level after 24 weeks of treatment.
Time Frame: After 24 weeks of treatment.
Secondary Outcomes
- 1)Body weight(2)Anthropometric measurements (Hip circumference, Hip-Waist ratio))