Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study
NCT ID: NCT05556291
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
190 participants
OBSERVATIONAL
2022-12-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Combinations of Oral Blood Glucose Lowering Drugs
Combination of Ertugliflozin and Sitagliptin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Primary Care Diabetes Association, Pakistan
OTHER
Getz Pharma
INDUSTRY
Responsible Party
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Locations
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Doctor's Plaza
Karachi, Sindh, Pakistan
Khan's Clinic
Karachi, Sindh, Pakistan
PECHS
Karachi, Sindh, Pakistan
Countries
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References
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International Diabetes Federation. IDF Diabetes Atlas, 10th edn.: International Diabetes Federation, 2021. http://www.diabetesatlas.org
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.
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.
Lin X, Xu Y, Pan X, Xu J, Ding Y, Sun X, Song X, Ren Y, Shan PF. Global, regional, and national burden and trend of diabetes in 195 countries and territories: an analysis from 1990 to 2025. Sci Rep. 2020 Sep 8;10(1):14790. doi: 10.1038/s41598-020-71908-9.
van Baar MJB, van Ruiten CC, Muskiet MHA, van Bloemendaal L, IJzerman RG, van Raalte DH. SGLT2 Inhibitors in Combination Therapy: From Mechanisms to Clinical Considerations in Type 2 Diabetes Management. Diabetes Care. 2018 Aug;41(8):1543-1556. doi: 10.2337/dc18-0588.
Verbrugge FH. Role of SGLT2 Inhibitors in Patients with Diabetes Mellitus and Heart Failure. Curr Heart Fail Rep. 2017 Aug;14(4):275-283. doi: 10.1007/s11897-017-0340-1.
Mazidi M, Rezaie P, Gao HK, Kengne AP. Effect of Sodium-Glucose Cotransport-2 Inhibitors on Blood Pressure in People With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of 43 Randomized Control Trials With 22 528 Patients. J Am Heart Assoc. 2017 May 25;6(6):e004007. doi: 10.1161/JAHA.116.004007.
Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.
Chung WK, Erion K, Florez JC, Hattersley AT, Hivert MF, Lee CG, McCarthy MI, Nolan JJ, Norris JM, Pearson ER, Philipson L, McElvaine AT, Cefalu WT, Rich SS, Franks PW. Precision Medicine in Diabetes: A Consensus Report From the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2020 Jul;43(7):1617-1635. doi: 10.2337/dci20-0022.
McNeill AM, Davies G, Kruger E, Kowal S, Reason T, Ejzykowicz F, Hannachi H, Cater N, McLeod E. Ertugliflozin Compared to Other Anti-hyperglycemic Agents as Monotherapy and Add-on Therapy in Type 2 Diabetes: A Systematic Literature Review and Network Meta-Analysis. Diabetes Ther. 2019 Apr;10(2):473-491. doi: 10.1007/s13300-019-0566-x. Epub 2019 Jan 28.
Shankar RR, Zeitler P, Deeb A, Jalaludin MY, Garcia R, Newfield RS, Samoilova Y, Rosario CA, Shehadeh N, Saha CK, Zhang Y, Zilli M, Scherer LW, Lam RLH, Golm GT, Engel SS, Kaufman KD. A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes. Pediatr Diabetes. 2022 Mar;23(2):173-182. doi: 10.1111/pedi.13279. Epub 2021 Dec 22.
Miller S, Krumins T, Zhou H, Huyck S, Johnson J, Golm G, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 Jan 8.
Pratley RE, Eldor R, Raji A, Golm G, Huyck SB, Qiu Y, Sunga S, Johnson J, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial. Diabetes Obes Metab. 2018 May;20(5):1111-1120. doi: 10.1111/dom.13194. Epub 2018 Jan 25.
Related Links
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International Diabetes Federation. IDF Diabetes Atlas, 10th edn.: International Diabetes Federation, 2021.
Other Identifiers
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GTZ-DM-006-22
Identifier Type: -
Identifier Source: org_study_id
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