Clinical trial NCT05556291: Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study
Official title: Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Efficacy
Safety
Tolerability
Keywords: Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
Collaborators: name: Primary Care Diabetes Association, Pakistan
First posted: 2022-09-27
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic uncontrolled on lifestyle modification and OADs

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in HbA1c% to the last-observation.
timeFrame: up to 24 weeks
measure: Change from baseline in fasting plasma glucose to the last- observation on treatment
timeFrame: 24 weeks
measure: Change from baseline in bodyweight & BMI
timeFrame: till 24 weeks
Secondary outcomes:
measure: Frequency of adverse events during the course of study follow-up
timeFrame: 24 weeks
measure: Frequency of serious adverse events
timeFrame: up to 24 weeks
measure: Percentage of patients who discontinued investigational drug due to adverse events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Doctor's Plaza
state: Sindh
city: Karachi
country: Pakistan
facility: Khan's Clinic
state: Sindh
city: Karachi
country: Pakistan
facility: PECHS
state: Sindh
Study officials:
References:
citation: International Diabetes Federation. IDF Diabetes Atlas, 10th edn.: International Diabetes Federation, 2021. http://www.diabetesatlas.org
citation: Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
citation: Aamir AH, Ul-Haq Z, Mahar SA, Qureshi FM, Ahmad I, Jawa A, Sheikh A, Raza A, Fazid S, Jadoon Z, Ishtiaq O, Safdar N, Afridi H, Heald AH. Diabetes Prevalence Survey of Pakistan (DPS-PAK): prevalence of type 2 diabetes mellitus and prediabetes using HbA1c: a population-based survey from Pakistan. BMJ Open. 2019 Feb 21;9(2):e025300. doi: 10.1136/bmjopen-2018-025300.
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