Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Plain English summary under review

Trial website

Contact information



Primary contact

Ms Julie Perry


Contact details

Cancer Research UK
Liverpool CR-UK Centre - Waterhouse Building
1-3 Brownlow Street
L69 3GL
United Kingdom

Additional identifiers

EudraCT number

2013-004264-60 number

Protocol/serial number


Study information

Scientific title

Compensatory changes in energy balance during dapagliflozin treatment in type 2 diabetes



Study hypothesis

This study is designed to study the mechanisms underlying the changes in energy balance that occur with dapagliflozin treatment for type 2 diabetes (T2DM), so that in the future it might be possible to develop interventions to optimise weight loss and therefore therapeutic benefit of this agent.

Ethics approval

First MREC approval date 09/06/2014, ref: 14/NW/0340

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control, Metabolic, Nutrition, Obesity


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 weeks periods) evaluation
4. 26 weeks treatment in total)
5. Study Entry : Single Randomisation only

Intervention type



Phase IV

Drug names


Primary outcome measures

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

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

Planned Sample Size: 52; UK Sample Size: 52; Description: primary outcome measure is energy intake(g) after 12weeks.52 subjects are required in order to detect a 12.5% change with 80% power and at a two-sided 5% level of significance using the method for a paired t-test.This estimate assumes a correlation between measurements of 0.7 and a between-subject standard deviation of 165.The change in energy intake of 12.5% is based on a baseline level of 460g.This allows for a drop-out rate of 20% and was calculated using PROC POWER in SAS 9.3

Participant 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) illness.
Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK
Liverpool CR-UK Centre - Waterhouse Building 1-3 Brownlow Street
L69 3GL
United Kingdom

Sponsor information


University of Liverpool

Sponsor details

Whelan Building
Brownlow Hill
United Kingdom

Sponsor type




Funder type


Funder name


Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/08/2016: Changed recruitment start date from 31/07/2015 to 03/08/2015