Phase 4
Completed N=196
To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients
Source: ClinicalTrials.gov NCT04445714 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest — 40; 0; 0; 4 events
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest |
40; 0; 0; 4 | — |
| PRIMARY Clinically Important or Significant Abnormalities in Safety Laboratory Values |
— | — |
| PRIMARY Clinically Important Abnormalities in ECG Values |
— | — |
| PRIMARY Clinically Important Abnormalities in Vital Signs (Pulse and Blood Pressure) |
— | — |
| PRIMARY Clinically Significant Abnormalities in Physical Examinations |
— | — |
| SECONDARY Glycated Haemoglobin (HbA1c) Change at Week 24 Compared to Baseline |
8.6; 7.4; -1.2 | <.0001 sig |
| SECONDARY Weight Change at Week 24 Compared to Baseline |
74.2; 72.2; -2.1 | <.0001 sig |
| SECONDARY Systolic Blood Pressure Change at Week 24 Compared to Baseline |
125.7; 124.5; -0.2 | 0.8416 |
| SECONDARY Fasting Plasma Glucose Change at Week 24 Compared to Baseline |
161.8; 136.7; -24.4 | <.0001 sig |
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
- 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.
- 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
Data sourced from ClinicalTrials.gov (NCT04445714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.