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

Study Overview
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Brief Summary
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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).

Detailed Description
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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 balance to receive either once daily oral CPL-2009-0031 140 mg or Sitagliptin 100 mg. After completing 12 weeks of study post-randomization for regulatory submission, patients will be instructed for continuation of extension phase of treatment and follow up upto 36 weeks. HbA1c will be measured at screening, baseline, 12 weeks, 24 weeks and 36 weeks of treatment. While, Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) measurement will be performed every 2 weeks. The enrolled patients will be monitored for safety (AE and SAE) throughout the study period.

Official Title
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Prospective, Randomized, Double Blind, Parallel Group, Two Arm, Comparative, Multicenter, Clinical Study to Compare Efficacy and Safety of Oral CPL-2009-0031 140 mg of Cadila Pharmaceutical Limited, India Against Innovator Sitagliptin 100 mg in Patients With Uncontrolled Type-2 Diabetes Mellitus (T2DM)

Conditions
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Uncontrolled Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CPL-2009-0031 140 mg
* Drug: Sitagliptin 100mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPL-2009-0031 140 mg<br>Single dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks | Drug: CPL-2009-0031 140 mg<br>* Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.<br>|
| Active Comparator: Sitagliptin 100 mg<br>Single dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks | Drug: Sitagliptin 100mg<br>* Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c level | To evaluate HbA1c levels between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg | Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Sugar (FBS) level | To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg | Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy | 
| Postprandial Blood Sugar (PPBS) level | To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg | Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy | 
| Frequency of Serious Adverse Events | Determination of safety and tolerability of CPL-2009-0031 140 mg versus Sitagliptin 100 mg based on Frequency of serious adverse events | From randomization to end of 12 week, 24 week and 36-weeks therapy | 
| Number of hypoglycemic events | Determine number and severity of hypoglycemic events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg | From randomization to end of 12 week, 24 week and 36-weeks therapy | 
| Frequency of adverse events | Determine frequency and severity of adverse events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg | From randomization to end of 12 week, 24 week and 36-weeks therapy |