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

Sponsor
Getz Pharma (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05556291
Collaborator
Primary Care Diabetes Association, Pakistan (Other)
190
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Combinations of Oral Blood Glucose Lowering Drugs

Study Design

Study Type:
Observational
Anticipated Enrollment :
190 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in HbA1c% to the last-observation. [up to 24 weeks]

    Efficacy

  2. Change from baseline in fasting plasma glucose to the last- observation on treatment [24 weeks]

    Efficacy

  3. Change from baseline in bodyweight & BMI [till 24 weeks]

    Efficacy

Secondary Outcome Measures

  1. Frequency of adverse events during the course of study follow-up [24 weeks]

    Safety

  2. Frequency of serious adverse events [up to 24 weeks]

    Safety

  3. Percentage of patients who discontinued investigational drug due to adverse events [up to 24 weeks]

    Tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Getz Pharma
  • Primary Care Diabetes Association, Pakistan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Getz Pharma
ClinicalTrials.gov Identifier:
NCT05556291
Other Study ID Numbers:
  • GTZ-DM-006-22
First Posted:
Sep 27, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Getz Pharma
Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin

Study Results

No Results Posted as of Oct 4, 2022