Clinical trial NCT04801199: Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uncontrolled Type 2 Diabetes Mellitus
Lead sponsor: Cadila Pharnmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
First posted: 2021-03-16
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in HbA1c level
timeFrame: Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy
Secondary outcomes:
measure: Fasting Blood Sugar (FBS) level
timeFrame: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
measure: Postprandial Blood Sugar (PPBS) level
timeFrame: Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy
measure: Frequency of Serious Adverse Events
timeFrame: From randomization to end of 12 week, 24 week and 36-weeks therapy
measure: Number of hypoglycemic events
timeFrame: From randomization to end of 12 week, 24 week and 36-weeks therapy
measure: Frequency of adverse events
timeFrame: From randomization to end of 12 week, 24 week and 36-weeks therapy
Other outcomes:
Locations:
city: Nellore
country: India
facility: A C Subba Reddy Government Medical College and Hospital
state: Andhra Pradesh
city: Guwahati
country: India
facility: Downtown Hospital
state: Assam
city: Vadodara
country: India
facility: SSG Hospital
state: Gujarat
city: Bangalore
country: India
facility: Bangalore Diabetes Centre
state: Karnataka
city: Nashik
country: India
facility: Dhadiwal Hospital
state: Maharashtra
city: Ulhasnagar
country: India
facility: Ashirwad Hospital & Research Centre
state: Maharashtra
city: Bīkaner
country: India
facility: S.P. Medical College and A.G. Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Bhandari Clinic & Research Centre
state: Rajasthan
city: Lucknow
country: India
facility: Sanjivini Lung Centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: Nilratan Sircar Medical College & Hospital
state: West Bengal
city: Kolkata
country: India
facility: Life Line Diagnostic Centre cum Nursing Home
state: West Bengal
city: Gandhinagar
country: India
facility: Apollo Hospital International Ltd
Study officials:
affiliation: Cadila Pharmaceutical Limited
name: Anil Avhad, MBBS
role: STUDY_DIRECTOR
References: