To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445714
• Other study ID #: D1683C00013
• Status: Completed
• Phase: Phase 4
• Start date: April 7, 2021
• Est. completion date: March 14, 2023

Study information

• Verified date: April 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

During the study, an AstraZeneca representative/delegate will have regular contacts with the study site, including visits to site for the site monitoring and source data verification activities. Electronic Case Report Forms (eCRF) will be used for data collection and query handling. The investigator will sign the completed electronic Case Report Forms. A copy of the completed electronic Case Report Forms will be archived at the study site. Authorized representatives of AstraZeneca or delegate, a regulatory authority, or an Ethics Committee may perform audits or inspections at the center's. Number and percentages of Incidence of adverse events will be presented, stratified by age/gender/baseline medications. Annualised event rate shall also be presented in addition to the incidence rate during the study. Mean change in HbA1C from baseline to 6 months for patients will be analysed using paired t test / Wilcoxon signed-rank test at 5% level of significance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• dapagliflozin and saxagliptin
Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Locations

Country	Name	City	State
India	Research Site	Bangalore
India	Research Site	Bhubaneswar
India	Research Site	Chandigarh
India	Research Site	Coimbatore
India	Research Site	Hyderabad
India	Research Site	Kolkata
India	Research Site	Lucknow
India	Research Site	Mohali
India	Research Site	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients	Number, frequency and percentages of incidence of adverse events (AEs) and serious adverse events (SAEs)	6 Months
Secondary	To assess the efficacy of fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients	Mean change in Glycated haemoglobin (HbA1c) from baseline to 6 months	6 Months