A clinical trial to study the effects of two drugs, Metformin Immediate Release and Metformin Extended Release in newly diagnosed type 2 diabetes mellitus patients.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2021/04/033194
- Lead Sponsor
- Bangalore Medical College and Research Institute
- Brief Summary
Type 2 Diabetes Mellitus is characterized byvariable degrees of insulin resistance as well as progressive deterioration inthe function of pancreatic β cells resulting in impaired insulin secretionwhich leads to hyperglycemia and subsequent complications.1 DiabetesMellitus is the 21st century pandemic, according to the International DiabetesFederation (IDF) statistics, global diabetes prevalence is 424.9 million (8.8% of the world population) with72.9 million from India. India will be the diabetic capital of the World with aprojected 134.3 million individuals with diabetes by 2045.2
American Diabetic Association recommends Metformin asfirst-line therapy for patients with type 2 diabetes mellitus at diagnosis3.Its potent blood glucose lowering efficacy, beneficial effects on body weightand lipid profile, proven safety record, low cost, protective effects oncardiovascular system have secured its place as the favored initial drug.4
Metformin is available as Immediate release (IR) andExtended release (XR) formulations. The therapeutic profile of metformin hasbeen established over decades of clinical use, largely using animmediate-release formulation that requires administration two or three timesdaily. Few studies are of the opinion that Extended release formulation hasadditional advantage such as once daily administration, good compliance, lessside effects. However, it is more expensive than immediate-release metformin.There is no consensus with the available literature regarding the superiorityof Extended release formulation in terms of Glycemic efficacy. 5-9
Considering all these facts, to further strengthenthe existing knowledge the present study is undertaken to evaluate the efficacyand safety of Metformin IR verses Metformin XR in patients with type 2 diabetesmellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
- 1.Newly diagnosed Type 2 Diabetes Mellitus Patients as per American Diabetes Association guidelines.3 2.Patients of either sex aged ≥18years to ≤60 years.
- 3.Patients willing to give written informed consent.
- 1.Newly diagnosed Type 2 diabetes mellitus patients with glycemic markers HbA1C>8.5, FBS>160mg/dl, PPBS> 260mg/dl.
- 2.Patients suffering with any other co-existing medical illness.
- 3.Patients not willing to give written informed consent.
- 4.Women who were pregnant or breastfeeding.
- 5.Patients with serum creatinine level > 1.2 mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the efficacy of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus. Baseline and Week 12 2.To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus. Baseline and Week 12
- Secondary Outcome Measures
Name Time Method .To compare the safety of Metformin Immediate Release versus Metformin Extended Release in patients with Type 2 Diabetes Mellitus. Week 4
Trial Locations
- Locations (1)
Victoria Hospital
🇮🇳Bangalore, KARNATAKA, India
Victoria Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Syed Salman FarookhPrincipal investigator9590292666ssfarookh@gmail.com