This study is being carried out to evaluate the effect of a drug calleddapagliflozin when added to current treatment for type 2 diabetes oncardiovascular events.

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 20.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-000239-28-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-27
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17150

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 run-in)
2. Female or male aged = 40 years
3. Diagnosed with T2DM (See Appendix E for details)
4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
- Established CV Disease (See Appendix E for details)
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 (see Appendix E for details)
- 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 8575

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 run-in 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 non-melanoma 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 non-cardiovascular 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 breast-feeding patients
Patients will be excluded during run-in and should not be randomized if
the following are observed from laboratory or observation during
enrollment and run-in 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 Cockroft-Gault equation)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified