Clinical Trial on Type 2 diabetes Mellitus (T2DM)
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/08/056886
- Lead Sponsor
- Theon Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Age: 18 to 65 years [both inclusive].
2. Gender: Male or female patients.
3. All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form.
4. All patients with type 2 diabetes mellitus.
5. Patients who have inadequate glycemic control to metformin monotherapy =1000 mg/day for at least 6 weeks.
6. Patients with HbA1c value between 7.5% and 10.5%.
1.Known hypersensitivity to linagliptin or dapagliflozin or to any of the excipients of the investigational products.
2.Patients with BMI = 40 kg/m2.
3.Laboratory findings measured at screening:
a. eGFR < 60 mL/min/1.73 m2 by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation
b. Hemoglobin <10 g/dl
c. Neutrophils < 2000/mm3
d. Platelets <100000/mm3
e. Total bilirubin > 1.5 times more than upper normal limit [ULN]
f. ALT/ AST > 2.5 times more than ULN
g. Serum amylase and/or lipase > 3 times more than ULN
h. Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study
4. Patients with Type 1 Diabetes Mellitus.
5. Patients with fasting plasma glucose of > 270 mg/dL
6. Patients with hypothyroidism or hyperthyroidism
7. Patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease
8. Patients who are on dialysis
9. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.)
10. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents
11. Patients with history of pancreatitis
12. Patients with pancreatic insulin deficiency from any cause, caloric restriction, or alcohol abuse
13. Patients with genital mycotic infections or urinary tract infections
14. Patients with hypotension requiring intervention
15. Patients who have used corticosteroids for one week or more within 3 months prior to screening
16. Patients with a prior history of heart failure
17. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology
18. Patients who had suffered from COVID-19 within 8 weeks prior to study drug administration or patients with suspected signs and symptoms of COVID-19/ confirmed novel coronavirus infection (COVID-19)
19. Women of child bearing potential not practicing any acceptable methods of contraception during study. For this study, acceptable and effective methods of contraception for females include at least one of the following:
a. Intrauterine device placed at least 6 months prior to the first study dose and agree to follow throughout the study
b. Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom)
c. Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
d. Females who are surgically sterile
e. Females who are post-menopausal for at least one year
f. Pregnant or lactating women
20.Patients with clinically significant medical history, vital signs, physical examination requiring exclusion of the patient as deemed by the investigator or designee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to evaluate the efficacy of fixed-dose combination Linagliptin 5 mg, Dapagliflozin 10 mg and Metformin hydrochloride 1000 mg vis-à-vis active control medication, i.e. linagliptin 5 mg on the basis of primary and secondary endpoints. <br/ ><br>Change in HbA1c levels from baseline to Week 16. <br/ ><br>Change in body weight from baseline to Week 16. <br/ ><br>Change in fasting plasma glucose (FPG) from baseline to Week16. <br/ ><br>Change in post-prandial blood glucose (PPG) levels from baseline to Week 16.Timepoint: Visit 0 is the baseline visit for screening followed by: <br/ ><br>Visit 1: Week 4 <br/ ><br>Visit 2: Week 8 <br/ ><br>Visit 3: Week 12 <br/ ><br>Visit 4: Week 16
- Secondary Outcome Measures
Name Time Method The secondary objective of this study is to evaluate the safety of fixed-dose combination of Linagliptin 5 mg, Dapagliflozin 10 mg and Metformin hydrochloride 1000 mg vis-à-vis active control medication, i.e. linagliptin 5 mg by comparing treatment-emergent adverse events or serious adverse events as well as comparison of baseline and end-of-study assessment by virtue of physical examination and clinical laboratory investigations.Timepoint: Visit 0 is the baseline visit for screening followed by: <br/ ><br>Visit 1: Week 4 <br/ ><br>Visit 2: Week 8 <br/ ><br>Visit 3: Week 12 <br/ ><br>Visit 4: Week 16