Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study (CEASE)

February 3, 2023 updated by: Getz Pharma

Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus

Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study to evaluate the efficacy, safety and tolerability of Ertugliflozin and Sitagliptin Con-initiation in patients with Type II Diabetes Mellitus in the Pakistani population. The study duration will be 12 months.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75330
        • Recruiting
        • Doctor's Plaza
        • Contact:
          • Verumal Lohano
      • Karachi, Sindh, Pakistan, 75330
        • Recruiting
        • Khan's Clinic
        • Contact:
          • Riasat Ali Khan, MBBS
      • Karachi, Sindh, Pakistan, 75330
        • Recruiting
        • PECHS
        • Contact:
          • Adnan HB Kanpurwala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic uncontrolled on lifestyle modification and OADs

Description

Inclusion Criteria:

  • Type 2 diabetic males & females between 18-65 years.
  • HbA1c: 7.0% - 10.0%
  • Patient uncontrolled on oral anti-diabetics and lifestyle modifications for at least 3 months.
  • eGFR >60 mL/min/1.73m2.
  • Patient who will give informed consent
  • Patient who are SGLT2i naïve

Exclusion Criteria:

  • History of severe hypoglycemia for the last three months (<70mg/dL)
  • Pregnant or lactating females
  • History of renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal
  • History of recurrent urinary tract infection (UTI) and/or past 3 months' history of UTI and its treatment
  • Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
  • History of acute coronary syndrome or myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack.
  • History of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Patient with diabetic foot ulcers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in HbA1c% to the last-observation.
Time Frame: up to 24 weeks
Efficacy
up to 24 weeks
Change from baseline in fasting plasma glucose to the last- observation on treatment
Time Frame: 24 weeks
Efficacy
24 weeks
Change from baseline in bodyweight & BMI
Time Frame: till 24 weeks
Efficacy
till 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events during the course of study follow-up
Time Frame: 24 weeks
Safety
24 weeks
Frequency of serious adverse events
Time Frame: up to 24 weeks
Safety
up to 24 weeks
Percentage of patients who discontinued investigational drug due to adverse events
Time Frame: up to 24 weeks
Tolerability
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Getz Pharma

Collaborators

Primary Care Diabetes Association, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (ACTUAL)

September 27, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GTZ-DM-006-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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