Ensayo en fase III de 24 semanas, internacional, aleatorizado, de grupos paralelos, doble ciego y controlado con placebo, con un período de extensión de 24 semanas, para evaluar la eficacia y la seguridad de la dapagliflozina añadida al tratamiento de los pacientes con diabetes de tipo 2 que tienen un control insuficiente de la glucemia con insulinaA 24-week international, randomized, parallel-group, double-blind, placebo-controlled Phase III study with a 24-week extension period to evaluate the efficacy and safety of dapagliflozin therapy when added to the therapy of patients with type 2 diabetes with inadequate glycaemic control on insulin.

Active, not recruiting

• Conditions: Diabetes mellitus tipo 2Type 2 Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitus

• Registration Number: EUCTR2007-007540-10-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-19
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Inclusion criteria at enrolment (visit 1):
1. Provision of a written informed consent
2. Men and women diagnosed with type 2 diabetes
3. Age =18 - =80 years at time of consenting
4. Patients with inadequate glycaemic control, defined as documented HbA1c =7.5%
and =10.5% and who are according to investigators judgement for a period of at
least 8 weeks prior to enrolment on a stable insulin regimen with a mean insulin
dose of least 30 IU of injectable insulin per day either without any other OADs or
with a stable dose of OADs that have been approved in combination with insulin.
Inclusion criteria before randomisation (visit 2):
1. Patients with HbA1c =7.5% and =10.5% according central laboratory values
measured from sample taken at visit 1 and who are on a stable insulin regimen with
a mean insulin dose of least 30 IU of injectable insulin per day either without any
other OADs or with a stable dose of OADs that have been approved in combination
with insulin.
2. Daily insulin requirements over the past seven days with insulin dose
documentation that does not vary more than 10% on more than one occasion of the
calculated mean daily insulin dose at visit two (For example for patient whose
calculated mean daily insulin dose at visit 2 is 50 IU, daily doses in the preceding
seven days with insulin dose documentation may not be <45 and >55 IU on more
than one occasion).
3. Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 4 weeks after
the study in such manner that the risk of pregnancy is minimized and must have a
negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
units of HCG) within 72 hours prior to the start of study medication. WOCBP include any female who has experienced menarche and who has not undergone
successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral
oophorectomy) or is not postmenopausal (defined as amenorrhea =12 consecutive
months; or women on hormone replacement therapy (HRT) with documented serum
follicle stimulating hormone (FSH) level >35mIU/mL).Even women who are using
oral, implanted or injectable contraceptive hormones or mechanical products such
as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to
prevent pregnancy or practicing abstinence or where the partner is sterile (eg
vasectomy), should be considered to be of child bearing potential.
4. Body Mass Index (BMI) = 45 kg/m2

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria at randomization visit (visit 2):
1. Clinical diagnosis of type 1 diabetes, MODY or secondary diabetes mellitus (eg
chronic pancreatitis, partial pancreatectomy).
2. Symptoms of poorly controlled diabetes that in judgement of the investigator would
preclude participation in this trial including, but not limited to, marked polyuria and
polydipsia with greater than 10% weight loss during the 3 months prior to
enrolment.
3. History of diabetes insipidus
4. Use of inhaled insulin or injectable GLP-1 receptor agonists or DPP-4 inhibitors
within 8 weeks of enrolment visit
5. Calculated Creatinine Clearance <50 ml/min/1.73m2 (calculated by Cockcroft-Gault
formula) or a measured serum creatinine value of >2mg/dl (177 µmol/l). Patients on
concomitant metformin therapy will be excluded if serum creatinine =1.5 mg/dl
(133 mmol/l) for male subjects and =1.4 mg/dl (124 mmol/l) for female subjects
6. Known condition of congenital renal glucosuria
7. Total bilirubin >34.2 mmol/l, >2.0 mg/dl (ULN)
8. Creatine kinase =3xULN
9. Hemoglobin =10.0 g/dl (=100 g/l) for men; hemoglobin =9.5 g/dl (=95 g/l) for
women
10. Thyroid-stimulating hormone (TSH) values outside normal range confirmed by
abnormal T4 values
11. Positive serologic evidence of current infectious liver disease including patients
being positive for Hepatitis B viral antibody IgM, Hepatitis B surface antigen and
Hepatitis C virus antibody.
12. Any clinically significant abnormality identified on physical examination, ECG or
laboratory tests, which in the judgement of the investigator would compromise the
patients’ safety or successful participation in the clinical study.
13. Significant cardiovascular history within the past 6 months prior to the screening
visit, defined as: myocardial infarction, unstable angina pectoris, transient ischemic
attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or
revascularization (coronary angioplasty or bypass grafts), or cerebrovascular
accident
14. Pregnant or breastfeeding patients
15. Treatment with glucocorticoids equivalent to oral prednisolone >10 mg
(betametasone >1.2 mg/dexametasone >1.5 mg/hydrocortisone >40 mg)/day within
30 days prior to enrolment; topical or inhaled corticosteroids are allowed
16. History of bariatric surgery
17. Administration of weight loss medication, including but not limited to sibutramine,
phentermine, orlistat, rimonabant, benzphetamine, diethylpropion,
methamphetamine, and/or phendimetrazine, within 30 days prior to enrolment
18. Treatment for Human immunodeficiency virus (HIV)/use of antiviral drugs
(delavirdine, indinavir, nelfinavir, ritonavir, saquinavir) and/or known
immunocompromised status, including patients who have undergone organ
transplantation
19. Intolerance, contraindication or potential allergy to dapagliflozin or placebo or
formulation recipients
20. Congestive heart failure defined as New York Heart Association (NYHA) class III
or IV (see Appendix D), and/or left ventricular ejection fraction of =40%
21. Severe respiratory failure or severe emphysema
22. Severe uncontrolled hypertension defined as systolic BP =180 mm Hg and/or
diastolic BP =110 mm Hg
23. Patients who, in the judgment of the investigator, may be at risk for dehydration
24. History of chronic hemolytic anemia or hemoglobinopathies (sickle cell anemia or
thalassemias, sideroblatic anemia)
25. History of alcohol abuse or illegal drug abuse within the past 12 months
26. History of malignancy within the la

Study & Design

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