Type 2 Diabetes MellitusPhase 4NCT04445714

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

A Phase 4 study testing dapagliflozin and saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 9 sites in India.

Completed

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

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: dapagliflozin and saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 9 sitesIndia
Study dates: 7 Apr 2021to 14 Mar 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For inclusion in the study subjects should fulfil the following criteria:
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.

Who cannot join

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

Show all 22Show fewer

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.
History of heart failure
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
History of diabetic ketoacidosis
Any acute/chronic systemic infections
Recurrent urogenital infections
Patients at risk for volume depletion as judged by the investigator
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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

India9 sites

Research Site
Bangalore, 560017
Research Site
Bhubaneswar, 751007
Research Site
Chandigarh, 160012
Research Site
Coimbatore, 641018
Research Site
Hyderabad, 500024
Research Site
Kolkata, 700020
Research Site
Lucknow, 226003
Research Site
Mohali, 160062
Research Site
New Delhi, 110076

Other trials in India

About this study

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

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.

Read the detailed 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: dapagliflozin and saxagliptin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

dapagliflozin and saxagliptinDrug
Also called QTERN Tablet
Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Study groups in NCT04445714
Study group	Role	What they receive
dapagliflozin and saxagliptin	Other	Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally Receives: Drug: dapagliflozin and saxagliptin

What is being measured

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

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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Enrolment (Week -1) to End of Study (Week 26)

Secondary outcomes (4)

Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring HbA1c change at week 24 compared to baseline.
Measured: Baseline to Week 24
Weight Change at Week 24 Compared to Baseline
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring weight change at week 24 compared to baseline.
Measured: Baseline to Week 24
Systolic Blood Pressure Change at Week 24 Compared to Baseline
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring systolic blood pressure change at week 24 compared to baseline.
Measured: Baseline to Week 24
Fasting Plasma Glucose Change at Week 24 Compared to Baseline
The efficacy of the fixed dose combination of dapagliflozin + saxagliptin in Indian Type 2 Diabetes Mellitus participants was analyzed by measuring fasting plasma glucose change at week 24 compared to baseline.
Measured: Baseline to Week 24

Timeline

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

7 Apr 202114 Mar 2023

First posted24 Jun 2020
Study start7 Apr 2021
Primary completion14 Mar 2023
Study completion14 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445714
Sponsor's protocol ID: D1683C00013
Status last verified: Sep 2024
First submitted: 4 Jun 2020
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04445714
Acronym / sponsor ID: D1683C00013
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Apr 2021 (actual)
Primary completion: 14 Mar 2023 (actual)
Study completion: 14 Mar 2023 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 12 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dapagliflozin and saxagliptin	Other	Drug: dapagliflozin and saxagliptinSinge arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dapagliflozin and saxagliptinAlso: QTERN TabletCombination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally	Drug	dapagliflozin and saxagliptin

Primary outcome

Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest
Time frame: Baseline to End of Study (Week 26)
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)
Clinically Important or Significant Abnormalities in Safety Laboratory Values
Time frame: Enrolment (Week -1) to End of Study (Week 26)
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.
Clinically Important Abnormalities in ECG Values
Time frame: Time Frame: Baseline to End of Study (Week 26)
The number of participants with clinically important abnormalities in ECG values are presented.
Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)
Time frame: Enrolment (Week -1) to End of Study (Week 26)
The number of participants with clinically important abnormalities in vital signs (pulse and blood pressure).
Clinically Significant Abnormalities in Physical Examinations
Time frame: Enrolment (Week -1) to End of Study (Week 26)
The number of participants with clinically significant abnormalities in physical examinations.

4 secondary outcomes

Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline
Time frame: Baseline to Week 24
Weight Change at Week 24 Compared to Baseline
Time frame: Baseline to Week 24
Systolic Blood Pressure Change at Week 24 Compared to Baseline
Time frame: Baseline to Week 24
Fasting Plasma Glucose Change at Week 24 Compared to Baseline
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg	196	173

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

Time frame: Baseline to End of Study (Week 26). Number. Unit: events

Measure	Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg n = 196
AEs	40
SAEs	0
DAEs	0
Adverse events of special interest	4

Population analysed: Safety Population

Primary outcome: Clinically Important or Significant Abnormalities in Safety Laboratory Values

Time frame: Enrolment (Week -1) to End of Study (Week 26). Count of participants. Unit: Participants

Measure	Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg n = 196
Value	0

Population analysed: Safety Population

Primary outcome: Clinically Important Abnormalities in ECG Values

Time frame: Time Frame: Baseline to End of Study (Week 26). Count of participants. Unit: Participants

Measure	Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg n = 196
Value	0

Population analysed: Safety Population

Primary outcome: Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure)

Time frame: Enrolment (Week -1) to End of Study (Week 26). Count of participants. Unit: Participants

Measure	Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg n = 196
Value	0

Population analysed: Safety Population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to End of Study (26 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fixed Dose Combination of Dapagliflozin 10 mg / Saxagliptin 5 mg	0 of 196 (0%)	22 of 196 (11.2%)	0 of 196

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSP redactedLink provided by the sponsor.
SAP redactedLink provided by the sponsor.
CSR Synopsis redactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Anil Bhansali principal investigator

Post Graduate Institute of Medical Education and Research, Chandigarh

Dr K P Singh principal investigator

Fortis Hospital Mohali

Dr Indira Pattnaik principal investigator

Sparsh Hospitals & Critical Care (P) Ltd, Bhubaneswar

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dapagliflozin and saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 9 sites in India.

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 22 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in India. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest (time frame: Baseline to End of Study (Week 26)). The study lists 5 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 NCT04445714.

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 12 Nov 2024.