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Completed

NCT Number: NCT05556291

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

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.

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Key information

Conditions

Efficacy Safety Tolerability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Doctor's Plaza, Karachi, Sindh, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combinations of Oral Blood Glucose Lowering Drugs

Drug

Combination of Ertugliflozin and Sitagliptin

Primary outcomes

  1. Change from baseline in HbA1c% to the last-observation.

    Time frame: up to 24 weeks

    Efficacy

  2. Change from baseline in fasting plasma glucose to the last- observation on treatment

    Time frame: 24 weeks

    Efficacy

  3. Change from baseline in bodyweight & BMI

    Time frame: till 24 weeks

    Efficacy

Secondary outcomes

  1. Frequency of adverse events during the course of study follow-up

    Time frame: 24 weeks

    Safety

  2. Frequency of serious adverse events

    Time frame: up to 24 weeks

    Safety

  3. Percentage of patients who discontinued investigational drug due to adverse events

    Time frame: up to 24 weeks

    Tolerability

Sponsors and collaborators

Lead sponsor

Getz Pharma

Industry

Collaborators

  • Primary Care Diabetes Association, Pakistan

Registry information

Official study title

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

Acronym: CEASE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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