This study is being carried out to evaluate the effect of a drug called dapagliflozin when added to current treatment for type 2 diabetes on cardiovascular events.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 17160

Inclusion Criteria

For inclusion in the study patients should fulfill the following criteria:
1. Provision of informed consent prior to any study specific procedures (including runin)
2. Female or male aged = 40 years
3. Diagnosed with T2DM 4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors: Established
CV Disease OR No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as: Age = 55 years in men and = 60 in women AND presence of at least 1 of the following additional risk factors
Dyslipidemia
Hypertension
Current Tobacco use
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7850

Exclusion Criteria

1. Use of the following excluded medications:
Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for a total of 2 years or more during lifetime Current or recent (within 12 months) treatment with rosiglitazone
Previous treatment with any SGLT2 inhibitor
Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone =10 mg (e.g., betamethasone =1.2 mg, dexamethasone =1.5 mg, hydrocortisone =40 mg) per day
2. Acute cardiovascular event[e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained ventricular tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the runin period as long as randomization does not occur within 8 weeks of the event.
3. Systolic BP> 180 or diastolic BP > 100 mmHg at randomization. Patient should be excluded if either the systolic BP is elevated (> 180 mmHg) or the diastolic BP is elevated (> 100 mmHg) on both measurements
4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
5. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
6. History of any other malignancy within 5 years (with the exception of successfully treated nonmelanoma skin cancers)
7. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
8. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not
limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or noncardiovascular disease (e.g., active malignancy with
the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5
years
9. Pregnant or breastfeeding patients Patients will be excluded during runin and should not be randomized if the following
are observed from laboratory or observation during enrollment and runin assessments:
10. HbA1c =12% or HbA1c<6.5% from the central laboratory (nb, the proportion of subjects with an HbA1c between 6.5 % and < 7.0 % will be
capped at approximately 5 % of the study)
11. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN 12. CrCl < 60 ml/min (based on the CockroftGault equation)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 12/21/2021

This study is being carried out to evaluate the effect of a drug called dapagliflozin when added to current treatment for type 2 diabetes on cardiovascular events.

Recruitment & Eligibility

Study & Design

Related Trials