Status:
COMPLETED
Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
Lead Sponsor:
Cadila Pharnmaceuticals
Collaborating Sponsors:
New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
Conditions:
Uncontrolled Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of or...
Detailed Description
In this phase-III trial, after due consent and completing initial 2-weeks of placebo run-in period with diet, exercise and counseling, eligible patients with uncontrolled T2DM will be randomized in ba...
Eligibility Criteria
Inclusion
- Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM).
- Patients with HbA1c ≥ 7 to 10 and those on oral hypoglycemic agents ≤ 2 other than Insulin and Gliptins.
- BMI in the range of 18.5 - 35 kg/m2.
- All patients must be willing to give informed consent and can understand \& complying protocol requirement.
- Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
- Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
Exclusion
- Those who are on insulin and not ready for wash out of 3 months.
- Those who are on gliptin and not ready for wash out of 3 months.
- Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes.
- Those scheduled for or who had undergone surgery.
- Those with a severe infection or serious injury
- Pregnant and lactating women.
- Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation.
- Hypertensive patients with blood pressure ≥160/100 mm of Hg.
- History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack.
- Debilitating neurological or psychiatric disorders
- History or currently consuming abusing drugs or alcohol.
- Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 2.5 X ULN and renal dysfunction as evidenced by creatinine level 2.5 X ULN).
- Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor.
- Patient has any concurrent illness which, in the opinion of the investigator or coinvestigator, may interfere with treatment or evaluation of safety or completion of this study.
- In the investigator's judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements.
- Participation in another clinical trial in the past 3 months.
- Patients with history of smoking or currently having smoking habit will not be included in the study.
Key Trial Info
Start Date :
January 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT04801199
Start Date
January 26 2020
End Date
February 11 2021
Last Update
August 17 2021
Active Locations (12)
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1
A C Subba Reddy Government Medical College and Hospital
Nellore, Andhra Pradesh, India, 524004
2
Downtown Hospital
Guwahati, Assam, India, 781006
3
SSG Hospital
Vadodara, Gujarat, India, 390001
4
Bangalore Diabetes Centre
Bangalore, Karnataka, India, 560043