A study to test effectiveness and safety of a diabetes drug in diabetic patients with severe disease of kidney

Phase 4

• Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

• Registration Number: CTRI/2018/12/016642
• Lead Sponsor: Shanmuga Hospital

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: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female subjects, age more than or equal to 18 years to less than or equal to 85 years at the time of informed consent

2. Uncontrolled Type 2 diabetes with a haemoglobin A1c (HbA1c) more than or equal to 7 percent and less than 10 percent

3. Patients with CKD defined by KDIGO 2017 criteria (KDIGO 2017 definition - CKD is defined as abnormalities of kidney structure or function, present for more than 3 months, with implications for health)

4. eGFR (MDRD) at screening more than or equal to 15 mL/min/1.73m2 to less than 90 mL/min/1.73m2 more than or equal to 3 months with or without kidney damage

5. Provide written informed consent

6. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

1. History of glucose-galactose malabsorption or primary renal glycosuria

2. Renal disease that required treatment with immunosuppressive therapy

3. Patients with hemodialysis

4. Blood potassium level > 5.5mmol/L during screening

5. Type 1 diabetes

6. Severe diabetic complications such as ketoacidosis

7. Females who are pregnant or breastfeeding

8. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal) that in the opinion of the investigator(s) could affect the subjectâ??s safety or interfere with the study assessments

9. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the subjectâ??s ability to safely complete the study

10. Hypersensitivity to the investigational product teneligliptin or any of the excipients

11. Known to be human immunodeficiency virus (HIV) positive

12. Active viral hepatitis (B or C) as demonstrated by positive serology

13. History of drug or alcohol dependency or abuse within approximately the last 2 years

14. Use of illegal recreational drugs

15. Currently enrolled in another clinical study or used any investigational product, study drug, or device within 90 days preceding informed consent or scheduled to participate in another clinical study involving an investigational product or Teneligliptin or investigational drug during the course of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified