Dapagliflozin energy balance in type 2 diabetes
| ISRCTN | ISRCTN14818531 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14818531 |
| EudraCT/CTIS number | 2013-004264-60 |
| Secondary identifying numbers | 19156 |
- Submission date
- 08/07/2015
- Registration date
- 08/07/2015
- Last edited
- 08/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary under review
Contact information
Ms Julie Perry
Scientific
Scientific
Cancer Research UK
Liverpool CR-UK Centre - Waterhouse Building
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Compensatory changes in energy balance during dapagliflozin treatment in type 2 diabetes |
| Study acronym | ENERGIZE |
| Study objectives | 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(s) | First MREC approval date 09/06/2014, ref: 14/NW/0340 |
| Health condition(s) or problem(s) studied | Topic: Diabetes; Subtopic: Type 2; Disease: Diabetic Control, Metabolic, Nutrition, Obesity |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Dapagliflozin |
| Primary outcome measure | To evaluate the effect of dapagliflozin 10mg daily compared to placebo |
| Secondary outcome measures | N/A |
| Overall study start date | 30/06/2015 |
| Completion date | 31/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| 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 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 03/08/2015 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Research UK
Liverpool CR-UK Centre - Waterhouse Building
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Sponsor information
University of Liverpool
University/education
University/education
Whelan Building, Quadrangle, Brownlow Hill
Liverpool
-
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Industry
AstraZeneca
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/01/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/02/2019: Overall trial end date changed from 31/12/2016 to 31/05/2019
30/01/2017: Publication reference added.
15/08/2016: Changed recruitment start date from 31/07/2015 to 03/08/2015
