Health Condition 1: null- Patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM) Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Oral CPL-2009-0031 70 mg tablet, Oral CPL-2009-0031 140 mg tablet: Each will be administered once daily for the duration of total 12-weeks
Control Intervention1: Oral Sitagliptin 50 mg
Sponsors
Cadila Pharmaceutical Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM). 2. Patients with HbA1c >= 7 and those on oral hypoglycemic agents other than Insulin and Gliptins. 3. BMI in the range of 18.5 â?? 35 kg/m2. 4.All patients must be willing to give informed consent and can understand & complying protocol requirement. 5. 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. 6. Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).
Exclusion criteria
Exclusion criteria: 1. Those who are on insulin. 2. Those who are on gliptin and not ready for wash out of 3 months. 3. Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes. 4. Those scheduled for or who had undergone surgery. 5. Those with a severe infection or serious injury; pregnant and lactating women. 6. Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation. 7. Hypertensive patients with blood pressure >=160/100 mm of Hg. 8. History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack. 9. Debilitating neurological or psychiatric disorders. 10. Participated in any clinical trial in last three months. 11. History or currently consuming abusing drugs or alcohol. 12. Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 1.5X ULN and renal dysfunction as evidenced by creatinine level 1.5X ULN). 13. Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor. 14. Patient has any concurrent illness which, in the opinion of the investigator or co-investigator, may interfere with treatment or evaluation of safety or completion of this study. 15. In the investigatorâ??s judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements. 16. Patients with history of smoking or currently having smoking habit will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose finding study to evaluate HbA1c levels between oral CPL-2009- 0031 (70 & 140 mg) against oral sitagliptin 50 mgTimepoint: Baseline and 12-weeks from onset of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of safety and tolerability of CPL-2009-0031 (70, 140 mg) versus Sitagliptin 50 mg based on: Frequency of serious adverse events 1.Number & severity of hypoglycemic events 2.Frequency and severity of adverse eventsTimepoint: Randomization to end of 12-week therapy;To compare Fasting and post-prandial glucoseTimepoint: Baseline, day-1 and end of 12-week therapy | — |
Countries
India
Contacts
Public ContactDr Sanjay Patel
Cadila Pharmaceuticals Limited
Outcome results
None listed