Dapagliflozin energy balance in type 2 diabetes

Phase 4

Recruiting

• Conditions: Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control, Metabolic, Nutrition, Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN14818531
• Lead Sponsor: niversity of Liverpool

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28132008

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-08
• Last Update Posted: 4 March 2019
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 52

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

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 (< 6 months) myocardial infarction
1.7. Previous stroke
1.8. Significant cardiac dysrhythmias (including pacemaker or ICD)
1.9. Known chronic liver disease (other than hepatic steatosis)
1.10. Familial renal glycosuria
1.11. History of seizures or unexplained syncope
1.12. Pregnancy
1.13. Recent major change in body weight (> 3kg loss or gain in preceding month)
1.14. Patients with very low BMI (<20kg/m2)
1.15. History of malignancy
1.16. Presence of any other medical condition that would, in the opinion of the investigator preclude safe participation in the study
1.17. Alcohol consumption in excess of daily recommended limits (14 units/week females, 21 units/week males)
1.18. Any history of internal metal, pacemakers, or ferromagnetic metallic implants intraocular foreign bodies or cerebral aneurysm clips (exclusion from MR scanning)
2. Physical and Laboratory Test Findings:
2.1. ALT > 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 <60 ml /min
2.6. Unexplained haematuria
2.7. Weight > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of dapagliflozin 10mg daily compared to placebo