To assess safety of fixed dose combination of dapagliflozin and saxagliptin in Type 2 Diabetes Mellitus patients

Study identifier:D1683C00013

ClinicalTrials.gov identifier:NCT04445714

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 4

Healthy volunteers

Study drug

dapagliflozin and saxagliptin

Sex

All

Actual Enrollment

200

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 07 Apr 2021

Estimated Primary Completion Date: 15 Dec 2022

Estimated Study Completion Date: 31 Mar 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2022 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

For inclusion in the study subjects should fulfil the following criteria:
1. Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
2. Male and female patients aged > 18 and above
3. Documented history of type 2 diabetes mellitus with HbA1c level >7.0% and ≤ 10% at screening visit
4. Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
5. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.

Exclusion Criteria

1. Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
2. Active participation in another clinical study with IP and/or investigational device
3. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
4. Type 1 diabetes mellitus.
5. Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
6. Patients with moderate to severe renal impairment (eGFR persistently <45 mL/min/1.73 m2 by CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula or end-stage renal disease (ESRD) or ‘Unstable or rapidly progressing renal disease
7. Patients with severe hepatic impairment (Child-Pugh class C)
8. History of pancreatitis or pancreatic surgery
9. Patients with a history of any malignancy
10. Patients with any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrolment, as assessed by the investigator:
• Myocardial infarction.
• Cardiac surgery or revascularization (CABG/PTCA).
• Unstable angina.
• Transient ischemic attack (TIA) or significant cerebrovascular disease.
• Unstable or previously undiagnosed arrhythmia.
11. History of heart failure
12. Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg at any visit up to randomisation
13. History of diabetic ketoacidosis
14. Any acute/chronic systemic infections
15. Recurrent urogenital infections
16. Patients at risk for volume depletion as judged by the investigator
17. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance

No locations available

Arms	Assigned Interventions
Other: dapagliflozin and saxagliptin Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Dr Anil Bhansali

Post Graduate Institute of Medical Education & Research Chandigarh