Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2021-02-11
• Target enrollment: 0
• Participant gender: All

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 oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Collaborator: New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.