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AzTrials

EfficacyCEASENCT05556291

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

An observational study of Efficacy and Safety, run by Getz Pharma at 3 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Efficacy, Safety, Tolerability
What is being tested?
Combinations of Oral Blood Glucose Lowering Drugs
Type of treatment
Pill or oral medicine
How many people
190 participants
Where
3 sitesPakistan
Study dates
1 Dec 2022to 1 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diabetic uncontrolled on lifestyle modification and OADs

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Pakistan3 sites

  • Doctor's Plaza

    Karachi, Sindh, 75330

  • Khan's Clinic

    Karachi, Sindh, 75330

  • PECHS

    Karachi, Sindh, 75330

Other trials in Pakistan

About this study

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

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.

Being tested
Combinations of Oral Blood Glucose Lowering Drugs
Keywords
Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combinations of Oral Blood Glucose Lowering DrugsDrug

    Combination of Ertugliflozin and Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Efficacy

    Measured: up to 24 weeks

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

    Efficacy

    Measured: 24 weeks

  3. Change from baseline in bodyweight & BMI

    Efficacy

    Measured: till 24 weeks

Secondary outcomes (3)

  1. Frequency of adverse events during the course of study follow-up

    Safety

    Measured: 24 weeks

  2. Frequency of serious adverse events

    Safety

    Measured: up to 24 weeks

  3. Percentage of patients who discontinued investigational drug due to adverse events

    Tolerability

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Jul 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05556291
Sponsor's protocol ID
GTZ-DM-006-22
Acronym
CEASE
Status last verified
Mar 2025
First submitted
23 Sep 2022
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32175717

  • 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.

    PubMed 30796126

  • 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.

    PubMed 32901098

  • 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.

    PubMed 30030256

  • 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.

    PubMed 28647919

  • 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.

    PubMed 28546454

  • 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.

    PubMed 18201203

  • 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.

    PubMed 32561617

  • 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.

    PubMed 30689140

  • 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.

    PubMed 34779087

  • 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.

    PubMed 29313282

  • 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.

    PubMed 29266675

Questions about this trial

What is this clinical trial studying?

An observational study of Efficacy and Safety, run by Getz Pharma at 3 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HbA1c% to the last-observation. (time frame: up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05556291, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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