Topic: Diabetes
Conditions
Interventions
1. Dapagliflozin 10mg /day or matching placebo administered orally (double-blind) crossover design
2. Short-term (2 x 7 day periods) evaluation
3. Long-term (2 x 12 wee
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes, either treated with diet alone or up to 2 other oral agents (excluding pioglitazone) with an HbA1c > 7.5% (58mmol/mol) and <11% (97 mmol/mol) 2. BMI 20-50kg/m2 3. Men and women, Age 18-75
Exclusion criteria
Exclusion criteria: 1. Medical History and Concurrent Diseases: 1.1. Type 1 diabetes mellitus 1.2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma 1.3. Hyperthyroidism 1.4. Hypothyroidism (subjects with a normal TSH and free T4, and on a stable dose of thyroxine for at least 3 months may be included) 1.5. Uncontrolled hypertension (blood pressure >150/90 mmHg) 1.6. Recent ( 3kg loss or gain in preceding month) 1.14. Patients with very low BMI ( 3 x ULN 2.2. AST > 3 x ULN 2.3. Bilirubin > 2 x ULN 2.4. Haemoglobin = 10.5 g/dL (= 105 g/L) for men; haemoglobin = 9.5 g/dL (= 95 g/L) for women 2.5. eGFR 150kg (due to limitations of MRI scanner) 3. Allergies and Adverse Drug Reactions: 3.1. Subjects with a history of any serious hypersensitivity reaction to dapagliflozin or SGLT-2 inhibitor 3.2. Subjects who are allergic or intolerant to any of the study foods in accordance with the Screening questionnaire 4. Sex and Reproductive Status – see below: 4.1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the study duration plus 8 weeks 4.2. Women who are pregnant or breastfeeding 4.3. Sexually active fertile men not using effective birth control if their partners are WOCBP 5. Prohibited Treatments and/or Therapies: 5.1. Diabetes treated with pioglitazone, GLP-1 analogues or insulin or any other SGLT-2 inhibitor 5.2. Use of other weight loss medication or any drug that might affect body weight or appetite (including anti-depressants, antipsychotics, corticosteroids) 5.3. Patients who are receiving dapagliflozin 5.4. Patients who have participated in a SGLT2 clinical trial within the past 30 days. 5.5. Patients who are currently receiving a loop diuretic 6. Other Exclusion Criteria: 6.1. Prisoners or subjects who are involuntarily incarcerated. 6.2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of dapagliflozin 10mg daily compared to placebo | — |
Countries
United Kingdom
Outcome results
None listed