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

Phase 3

Completed

• Conditions: Uncontrolled Type 2 Diabetes Mellitus
• Interventions: Drug: CPL-2009-0031 140 mg; Drug: Sitagliptin 100mg

• Registration Number: NCT04801199
• Lead Sponsor: Cadila Pharnmaceuticals

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

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 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.

Study Timeline

• Study Start: 2020-01-26
• Primary Completion: 2021-01-13
• Study Completion: 2021-02-11
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-13
• Study First Posted: 2021-03-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-14
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPL-2009-0031 140 mg	CPL-2009-0031 140 mg	Single dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks
Sitagliptin 100 mg	Sitagliptin 100mg	Single dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Life Line Diagnostic Centre cum Nursing Home; 🇮🇳 Kolkata, West Bengal, India

Sanjivini Lung Centre; 🇮🇳 Lucknow, Uttar Pradesh, India

Bangalore Diabetes Centre; 🇮🇳 Bangalore, Karnataka, India

SSG Hospital; 🇮🇳 Vadodara, Gujarat, India

Downtown Hospital; 🇮🇳 Guwahati, Assam, India

A C Subba Reddy Government Medical College and Hospital; 🇮🇳 Nellore, Andhra Pradesh, India

Dhadiwal Hospital; 🇮🇳 Nashik, Maharashtra, India

S.P. Medical College and A.G. Hospital; 🇮🇳 Bīkaner, Rajasthan, India

Bhandari Clinic & Research Centre; 🇮🇳 Jaipur, Rajasthan, India

Ashirwad Hospital & Research Centre; 🇮🇳 Ulhasnagar, Maharashtra, India

Nilratan Sircar Medical College & Hospital; 🇮🇳 Kolkata, West Bengal, India

Apollo Hospital International Ltd; 🇮🇳 Gandhinagar, India