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

NCT04445714 | Completed Phase 4 Results DMC

• 1 other identifier: D1683C00013
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest

  Adverse events (AEs) including serious adverse events (SAEs), AEs leading to discontinuation (DAE), and adverse events of special interest (volume depletion, renal events, major hypoglycemic events, fractures, urinary/genital tract infections diabetic ketoacidosis, amputations and hospitalization for heart failure)

  Baseline to End of Study (Week 26)

• Clinically Important or Significant Abnormalities in Safety Laboratory Values

  Clinical laboratory results were presented separately for haematology, clinical chemistry, and urinalysis variables. The number of participants with clinically important (haematology and clinical chemistry) or clinically significant (urinalysis) abnormalities in safety laboratory values are presented.

  Enrolment (Week -1) to End of Study (Week 26)

• Clinically Important Abnormalities in ECG Values

  The number of participants with clinically important abnormalities in ECG values are presented.

  Time Frame: Baseline to End of Study (Week 26)

• Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)

  The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure).

  Enrolment (Week -1) to End of Study (Week 26)

• Clinically Significant Abnormalities in Physical Examinations

  The number of participants with clinically significant abnormalities in physical examinations.

  Enrolment (Week -1) to End of Study (Week 26)

Secondary Outcomes (4)

• Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline

  Baseline to Week 24

• Weight Change at Week 24 Compared to Baseline

  Baseline to Week 24

• Systolic Blood Pressure Change at Week 24 Compared to Baseline

  Baseline to Week 24

• Fasting Plasma Glucose Change at Week 24 Compared to Baseline

  Baseline to Week 24

Study Arms (1)

dapagliflozin and saxagliptin

OTHER

Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Drug: dapagliflozin and saxagliptin

Interventions

dapagliflozin and saxagliptin DRUG

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

Also known as: QTERN Tablet

dapagliflozin and saxagliptin

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures according to local Indian procedure.
• Male and female patients aged \> 18 and above
• Documented history of type 2 diabetes mellitus with HbA1c level \>7.0% and ≤ 10% at screening visit
• Patients who are on a stable dose of antidiabetic drugs (including on Metformin dose between 1000-2000mg) in the past 3 months
• 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.

You may not qualify if:

• Known allergies or contraindication to the contents of the IP, dapagliflozin or saxagliptin tablets.
• Active participation in another clinical study with IP and/or investigational device
• For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• Type 1 diabetes mellitus.
• Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2
• 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
• Patients with severe hepatic impairment (Child-Pugh class C)
• History of pancreatitis or pancreatic surgery
• Patients with a history of any malignancy
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Bangalore, 560017, India

Location

Research Site

Bhubaneswar, 751007, India

Location

Research Site

Chandigarh, 160012, India

Location

Research Site

Coimbatore, 641018, India

Location

Research Site

Hyderabad, 500024, India

Location

Research Site

Kolkata, 700020, India

Location

Research Site

Lucknow, 226003, India

Location

Research Site

Mohali, 160062, India

Location

Research Site

New Delhi, 110076, India

Location

Related Links

• CSP redacted
• SAP redacted
• CSR Synopsis redacted

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Dr Anil Bhansali

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Dr K P Singh

  Fortis Hospital Mohali

  PRINCIPAL INVESTIGATOR

• Dr Indira Pattnaik

  Sparsh Hospitals & Critical Care (P) Ltd, Bhubaneswar

  PRINCIPAL INVESTIGATOR

• Dr Sandeep Kumar Gupta

  M V Hospital &Research centre Lucknow

  PRINCIPAL INVESTIGATOR

• Dr Faraz Farishta

  Thumbay Hospital New Life Hyderabad

  PRINCIPAL INVESTIGATOR

• Dr Girithara Jayaram Naidu

  KG Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 24, 2020
• Study Start: April 7, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'

Locations

IN (9)