Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2022
See protocol details

Summary

Principal SponsorGetz Pharma
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus
NCT05556291
Principal SponsorGetz Pharma
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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.
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8 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Doctor's Plaza

Karachi, PakistanOpen Doctor's Plaza in Google Maps
Suspended

Khan's Clinic

Karachi, Pakistan
Suspended

PECHS

Karachi, Pakistan
Completed3 Study Centers