A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patients
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Standard of Care
- Registration Number
- NCT02616666
- Lead Sponsor
- University of Liverpool
- Brief Summary
A trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)
- Detailed Description
A longitudinal, open labelled, pragmatic randomized 104 week multicentre trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and Standard of Care (SOC)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 632
For inclusion in the study patients should fulfil the following criteria at the time of screening:
- Provision of informed consent prior to any study specific procedures
- Females and males aged ≥18 years up to ≤ 75 years
- Diagnosed with Type 2 Diabetes Mellitus.
- Uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and HbA1c > 6.5%.
- Ability to read and write as judged by the investigator.
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrolment or randomization in the present study
- Age > 75 years
- Pregnancy/active breast feeding at the time of inclusion
- Known moderate to severe renal impairment (eGFR<60ml/min).
- Participation in an interventional clinical trial ≤ 3 months before enrolment.
- Unsuitable to participate on mental health grounds, as judged by the investigator.
- Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a SGLT2 inhibitor different from dapagliflozin.
- Presence of any of the characteristics in which the products in study are contraindicated, as per current labels.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SOC) Standard of Care Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication. Dapagliflozin 10 mg Dapagliflozin Patients will be randomized to receive either dapagliflozin or SOC. As this is a pragmatic trial, there will be no additional interventions (apart from collection of PROs and occurrence of hypoglycaemias) and there will be no restriction on how GPs change the randomized treatment regimen (e.g., switch or add drugs). Patients will be followed up for 2 years (+ 12 weeks = 116 weeks) after randomization, regardless of the status of medication.
- Primary Outcome Measures
Name Time Method Proportion of patients achieving clinical success as measured by a 4-item composite endpoint. Assessment of outcome measure will be made at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks). Proportion of patients achieving clinical success as measured by a 4-item composite endpoint including HbA1c reduction vs. baseline (≥ 0.5%), weight loss vs. baseline (≥ 2 Kg), no reported severe or documented hypoglycaemic events since randomization, and no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC),at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).
- Secondary Outcome Measures
Name Time Method To assess differences between dapagliflozin and SOC in the proportion of patients needing antihypertensive escalation (dose up titration, switch and add-on strategies), up to 52 weeks following randomization and separately, up to 104 weeks following randomization. Antihypertensive initiation or escalation (dose up titration, switch and add-on strategies), up to 52 weeks following randomization and separately, up to 104 weeks following randomization.
To assess differences between dapagliflozin and SOC in the healthcare resource utilization up to 52 weeks following randomization and separately, up to 104 weeks following randomization up to 52 weeks following randomization and separately, up to 104 weeks following randomization. Hospitalizations, contacts due to hypoglycaemic events, needing insulin treatment, complications and unscheduled GP visits, up to 52 weeks following randomization and separately, up to 104 weeks following randomization
To assess differences between dapagliflozin and SOC in the patients worry related to the risk of hypoglycaemic episodes measured b HFS-II Worry Scale at 6,12, 18 and 24 months At 6, 12, 18 and 24 months To assess differences between dapagliflozin and SOC in the patients worry related to the risk of hypoglycaemic episodes measured b HFS-II Worry Scale at 6,12, 18 and 24 months
To assess differences between dapagliflozin and SOC in the patients satisfaction with treatment as measured by the DTSQ at 6, 12, 18 and 24 months At 6, 12, 18 and 24 months To assess differences between dapagliflozin and SOC in the patients satisfaction with treatment as measured by the DTSQ at 6, 12, 18 and 24 months
To assess differences between dapagliflozin and SOC in the patients health related quality of life as measured by SF35v2 at 6, 12, 18 and 24 months At 6, 12, 18 and 24 months To assess differences between dapagliflozin and SOC in the patients health related quality of life, specifically physical, functioning, role functioning and vitality domains as measured by SF35v2 at 6, 12, 18 and 24 months
To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) Closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks) To assess differences between dapagliflozin and SOC in the change from baseline in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).
HbA1c success (HbA1c reduction vs. baseline ≥ 0.5%) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks). From randomization to 104 weeks of follow up. HbA1c reduction
To assess differences between dapagliflozin and SOC in the change from baseline in HbA1 HbA1c at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closet to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks). HbA1c at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).
To assess differences between dapagliflozin and SOC in the proportion of patients not switching from or adding to the treatment to which the patient was randomized ( up to 52 weeks following randomization and separately, up to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks). Switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC) up to 52 weeks following randomization and separately, up to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).
To assess differences between dapagliflozin and SOC in the proportion of patients with diabetic complications: up to 52 weeks following randomization and separately, up to 104 weeks following randomization. Proportion of patients with the following diabetic complications:
1. Heart failure
2. Gangrene or amputation of the leg, foot or toe
3. Diabetic ketoacidosis
4. Cerebrovascular disease
5. Nonfatal myocardial infarction
6. Blindness
7. NeuropathyTo assess differences between dapagliflozin and SOC in the change from baseline in eGFR closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks). eGFR (ml/min) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks).
Weight loss success (weight vs. baseline ≥ 2 Kg) at the clinical evaluation that occurs closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks). closest to 52 weeks of follow-up and separately, closest to 104 weeks of follow-up (in both cases, allowing a window of 12 weeks) Weight Loss success
Severe or documented hypoglycaemic events up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks). Up to 52 weeks following randomization and separately, up to 104 weeks following randomization (in both cases, allowing a window of 12 weeks). Documented Hypoglycaemic events
Trial Locations
- Locations (3)
Research Site
🇬🇧Wembley, United Kingdom
Research Site, Alum Rock
🇬🇧Birmingham, United Kingdom
Research Site, Market Square
🇬🇧Kineton, United Kingdom