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

Safety Clinical Trial

— CEASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556291
• Other study ID #: GTZ-DM-006-22
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2023
• Source: Getz Pharma
• Contact: Asima Khan, MBBS
• Phone: 03360896002
• Email: drasimakhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy
• Safety
• Tolerability

Intervention

Drug:
• Combinations of Oral Blood Glucose Lowering Drugs
Combination of Ertugliflozin and Sitagliptin

Locations

Country	Name	City	State
Pakistan	Doctor's Plaza	Karachi	Sindh
Pakistan	Khan's Clinic	Karachi	Sindh
Pakistan	PECHS	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Getz Pharma	Primary Care Diabetes Association, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Diabetes Care. 2019 Oct;42(10):2015. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c% to the last-observation.	Efficacy	up to 24 weeks
Primary	Change from baseline in fasting plasma glucose to the last- observation on treatment	Efficacy	24 weeks
Primary	Change from baseline in bodyweight & BMI	Efficacy	till 24 weeks
Secondary	Frequency of adverse events during the course of study follow-up	Safety	24 weeks
Secondary	Frequency of serious adverse events	Safety	up to 24 weeks
Secondary	Percentage of patients who discontinued investigational drug due to adverse events	Tolerability	up to 24 weeks

External Links

•   International Diabetes Federation. IDF Diabetes Atlas, 10th edn.: International Diabetes Federation, 2021.