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

Study of effect of teneligliptin versus glimepiride on tumor necrosis factor alpha (TNF- α) and high sensitivity C- reactive protein (hs-CRP) in type 2 diabetes mellitus patients treated with metformin. - TNF/CRP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012603
Enrollment
40
Registered
2018-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Teneligliptin: Teneligliptin 20mg/day per oral for 12 weeks Control Intervention1: Glimepiride: Glimepiride upto 4mg/day per oral for 12 weeks

Sponsors

MALEHA BUTUL
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. II. To monitor tolerability of teneligliptin and glimepiride. Timepoint: 0,4,12 weeks—

Countries

India

Contacts

Public ContactMALEHA BUTUL

Nizams Institute of Medical Sciences

ushapingali@yahoo.com9849574143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026