Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
Intervention1: Teneligliptin: 20 mg once daily for 6 months
Control Intervention1: Standard Treatment: As per discretion of Investigator
Sponsors
Shanmuga Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c at 24 weeks from baseline compared to standard treatmentTimepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in FBG and PPBG at 24 weeks from baseline compared to standard treatment 2. Change in eGFR at 24 weeks from baseline compared to standard treatment 3. Change in Urinary Albumin excretion at 24 weeks compared to standard treatmentTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr R Karthikeyan
Shanmuga Hospitals
Outcome results
None listed