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

NCT05556291 | Completed FDA Drug

• 1 other identifier: GTZ-DM-006-22
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 3

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.

Conditions

Efficacy; Safety; Tolerability

Keywords

Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin

Outcome Measures

Primary Outcomes (3)

• Change from baseline in HbA1c% to the last-observation.

  Efficacy

  up to 24 weeks

• Change from baseline in fasting plasma glucose to the last- observation on treatment

  Efficacy

  24 weeks

• Change from baseline in bodyweight & BMI

  Efficacy

  till 24 weeks

Secondary Outcomes (3)

• Frequency of adverse events during the course of study follow-up

  24 weeks

• Frequency of serious adverse events

  up to 24 weeks

• Percentage of patients who discontinued investigational drug due to adverse events

  up to 24 weeks

Interventions

Combinations of Oral Blood Glucose Lowering Drugs DRUG

Combination of Ertugliflozin and Sitagliptin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic uncontrolled on lifestyle modification and OADs

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Getz Pharma: lead
• Primary Care Diabetes Association, Pakistan: collaborator

Study Sites (3)

Doctor's Plaza

Karachi, Sindh, 75330, Pakistan

Location

Khan's Clinic

Karachi, Sindh, 75330, Pakistan

Location

PECHS

Karachi, Sindh, 75330, Pakistan

Location

Related Publications (13)

• International Diabetes Federation. IDF Diabetes Atlas, 10th edn.: International Diabetes Federation, 2021. http://www.diabetesatlas.org

  BACKGROUND

• 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.

  PMID: 32175717 BACKGROUND

• 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.

  PMID: 30796126 BACKGROUND

• 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.

  PMID: 32901098 BACKGROUND

• 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.

  PMID: 30030256 BACKGROUND

• 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.

  PMID: 28647919 BACKGROUND

• 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.

  PMID: 28546454 BACKGROUND

• 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.

  PMID: 18201203 BACKGROUND

• 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.

  PMID: 32561617 BACKGROUND

• 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.

  PMID: 30689140 BACKGROUND

• 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.

  PMID: 34779087 BACKGROUND

• 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.

  PMID: 29313282 BACKGROUND

• 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.

  PMID: 29266675 BACKGROUND

Related Links

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)