A clinical trial to evaluate the safety and efficacy of a fixed dose combination of three antidiabetic drugs versus two antidiabetic drugs in patients with type 2 diabetes mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/12/038472
- Lead Sponsor
- Alkem Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing to provide voluntary written informed consent and able to comply with the protocol requirements
2. Male or female patients with Type 2 DM of 18 to 65 years of age (both inclusive)
3. Patients who have inadequate glycaemic control to metformin � 1500 mg/day for at least 6 weeks
4. Patients with HbA1c value between 8.0% and 11.0% (both inclusive)
1. Known hypersensitivity to metformin, sitagliptin or pioglitazone or to any of the excipients of the investigational products
2. Patients with BMI � 40 kg/m2
3. Laboratory findings measured at screening:
a. Creatinine clearance (eGFR) < 50 mL/min by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation and/or serum creatinine levels � 1.5 mg/dL for men, � 1.4 mg/dL for women
b. Hemoglobin <10 g/dl
c. Neutrophils < 2000/mm3
d. Platelets <100,000/mm3
e. Total bilirubin > 1.5 X ULN
f. ALT/ AST > 2.5 X ULN
g. Serum amylase and/or lipase > 3 X ULN
h. Any other screening laboratory value that is clinically significant in the Investigatorââ?¬•s opinion precluding patientââ?¬•s participation in the study
4. Patients with Type 1 DM
5. Patients with fasting plasma glucose of > 270 mg/dL
6. Patients with history of macular edema
7. Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.)
8. Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents
9. Patients who have used corticosteroids for one week or more within 3 months prior to screening
10. Patients with history of acute or chronic cardiovascular or respiratory disease including myocardial infarction, coronary artery disease or shock
11. Patients with cardiac failure or history of cardiac failure (NYHA stages I to IV)
12. Patients with history of bladder cancer or currently presenting with any sign or symptoms suggestive of bladder cancer
13. Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology
14. 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) or with history of travel / contact with any COVID-19 positive patient/isolation/quarantine
15. Women of childbearing potential not practicing any acceptable methods of contraception during study. For this study, acceptable and effective methods of contraception for females include:
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)
OR
d. Females who are surgically sterile
OR
e. Females who are post-menopausal for at least one year
16. Pregnant or lactating women
17. Patients with clinically significant medical history, vital signs, physical examination as deemed by the investigator or designee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c levels from baseline to Week 24Timepoint: Baseline to 24 weeks
- Secondary Outcome Measures
Name Time Method 1. Change in body weight from baseline to Week 24 <br/ ><br>2. Change in fasting plasma glucose (FPG) and post-prandial blood glucose (PPG) from baseline to Week 24 <br/ ><br>3. To evaluate the safety and tolerability of the investigational product <br/ ><br>Timepoint: Baseline to 24 weeks