Study of antidiabetic drugs on markers of inflammation in type 2 diabetes mellitus patients.

Not Applicable

• Conditions: Health Condition 1: null- type 2 diabetes patients on tab. metformin 2500mg/day

• Registration Number: CTRI/2018/03/012603
• Lead Sponsor: MALEHA BUT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Body mass index (BMI) more than 25 kg/m2

2.All type 2 DM patients with a history of diabetes for the past 1 to 3 years

3.Type 2 diabetics with fasting blood sugar more than 126mg/dl and glycosylated hemoglobin (HbA1c) between 7.0 to 10.0 % before enrollment.

4.All type 2 DM patients, who are on stable dose of metformin (up to 2500mg/day) for the past 12 weeks.

5.All patients naive to teneligliptin and glimepiride.

6.All patients willing to give consent to participate in the study.

Exclusion Criteria

1.Uncontrolled hypertension (systolic BP more than or equal to 180 mmHg and diastolic BP more than or equal to 100 mmHg)

2.Uncontrolled diabetes (HbA1c more than or equal to 10.0 %).

3.Patientâ??s having serum creatinine (SCr) levels more than or equal to 2mg/dL.

4.Patients with hepatic impairment (AST and ALT levels more than or equal to 3 times the upper limit).

5.Serum triglycerides more than or equal to 500mg/dl.

6.Pregnant females and lactating mothers

7.History of hypersensitivity to study drugs.

8.History of taking non steroidal anti-inflammatory drugs or any other drugs that affect the study parameters.

9.Patients on any other herbal and dietary supplements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
I.To study the effect of teneligliptin (20mg/day) versus glimepiride (up to 4mg/day) on tumor necrosis factor-α (TNF- α) and high sensitivity C-reactive protein (hs-CRP) in type 2 diabetes mellitus patients treated with metformin (up to 2500mg/day).Timepoint: 0,4,12 week

Secondary Outcome Measures

Name	Time	Method
I.To observe the trend in diabetic polyneuropathy as assessed by the change in vibration perception threshold in type 2 diabetes patients when treated with teneligliptin and glimepiride. <br/ ><br>II.To monitor tolerability of teneligliptin and glimepiride. <br/ ><br>Timepoint: 0,4,12 weeks