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

Uncontrolled Type 2 Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04801199
• Other study ID #: CRSC18005
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: August 2021
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: February 11, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Uncontrolled Type 2 Diabetes Mellitus

Intervention

Drug:
• CPL-2009-0031 140 mg
Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.
• Sitagliptin 100mg
Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.

Locations

Country	Name	City	State
India	Bangalore Diabetes Centre	Bangalore	Karnataka
India	S.P. Medical College and A.G. Hospital	Bikaner	Rajasthan
India	Apollo Hospital International Ltd	Gandhinagar
India	Downtown Hospital	Guwahati	Assam
India	Bhandari Clinic & Research Centre	Jaipur	Rajasthan
India	Life Line Diagnostic Centre cum Nursing Home	Kolkata	West Bengal
India	Nilratan Sircar Medical College & Hospital	Kolkata	West Bengal
India	Sanjivini Lung Centre	Lucknow	Uttar Pradesh
India	Dhadiwal Hospital	Nashik	Maharashtra
India	A C Subba Reddy Government Medical College and Hospital	Nellore	Andhra Pradesh
India	Ashirwad Hospital & Research Centre	Ulhasnagar	Maharashtra
India	SSG Hospital	Vadodara	Gujarat

Sponsors (2)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Clinical trial database uploaded on Clinical Trial Registry of India (CTRI)