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

G

Getz Pharma

Status

Completed

Conditions

Efficacy
Tolerability
Safety

Treatments

Drug: Combinations of Oral Blood Glucose Lowering Drugs

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05556291
GTZ-DM-006-22

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Central trial contact

Hussain Abidi, MBBS; Asima Khan, MBBS

Data sourced from clinicaltrials.gov

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