104 Week Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study.

• Register: EUCTR
• Last refreshed on: 26 October 2020
• Main ID: EUCTR2015-001873-42-GB
• Date of registration: 01/09/2015
• Prospective Registration: Yes
• Primary sponsor: University of Liverpool
• Public title: 104 Week Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study.
• Scientific title: Pragmatic Randomised 104 Week Multicentre Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study. - DECIDE
• Date of first enrolment: 27/10/2015
• Target sample size: 872
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001873-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Enquires
• Affiliation: Clinical Practice Research Datalink (CPRD)

• Name: Enquires
• Affiliation: Clinical Practice Research Datalink (CPRD)

Key inclusion & exclusion criteria

Inclusion criteria:
For inclusion in the study patients should fulfil the following criteria at the time of screening:
1. Provision of informed consent prior to any study specific procedures
2. Females and males aged =18 years
3. Diagnosed with Type 2 Diabetes Mellitus.
4. Uncontrolled on first-line metformin treatment, defined as =8 weeks on maximum tolerated dose of metformin and HbA1c > 6.5%.
5. Ability to read and write as judged by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 676
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 196

Exclusion criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff
and/or staff at the study site)
2. Previous enrolment or randomization in the present study
3. Age > 75 years
4. Pregnancy/active breast feeding at the time of inclusion
5. Known moderate to severe renal impairment (eGFR<60ml/min).
6. Participation in an interventional clinical trial = 3 months before enrolment.
7. Unsuitable to participate on mental health grounds, as judged by the investigator.
8. Physician decision to use, as second line treatment, insulin, a GLP1 agonist compound or a
SGLT2 inhibitor different from dapagliflozin.
9. Presence of any of the characteristics in which the products in study are contraindicated, as
per current labels.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Type 2 diabetes mellitus
MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861

Intervention(s)

Trade Name: FORXIGA
Product Name: Forxiga
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dapagliflozin propanediol monohydrate
CAS Number: 960404-48-2
Other descriptive name: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Pharmaceutical Form:

Pharmaceutical Form: Tablet
INN or Proposed INN: repaglinide
CAS Number: 135062-02-1
Other descriptive name: REPAGLINIDE

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: nateglinide
CAS Number: 105816-04-4
Other descriptive name: NATEGLINIDE

Pharmaceutical Form:

Pharmaceutical Form: Tablet
INN or Proposed INN: pioglitazone
Other descriptive name: PIOGLITAZONE HYDROCHLORIDE

Trade Name: XIGDUO
Product Name: Xigduo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dapagliflozin propanediol monohydrate
CAS Number: 960404-48-2
Other descriptive name: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: metformin
Other descriptive name: METFORMIN HYDROCHLORIDE

Pharmaceutical Form:
INN or Proposed INN: metformin
Other descriptive name: METFORMIN HYDROCHLORIDE

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: pioglitazone
Other descriptive name: PIOGLITAZONE HYDROCHLORIDE
INN or Proposed INN: metformin
Other descriptive name: METFORMIN HYDROCHLORIDE

Pharmaceutical Form: Tablet
INN or Proposed INN: acarbose
CAS Number: 56180-94-0
Other descriptive name: ACARBOSE

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).

Main Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months post-randomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint, at the clinical evaluation that occurs closest to 52 weeks of follow-up (allowing a window of 12 weeks).

Primary end point(s): HbA1c reduction vs. baseline (= 0.5%), weight loss vs. baseline (= 2 Kg), no severe or documented
hypoglycaemic events since the last (most recent) clinical assessment, and no switching from
or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC).

Secondary Objective: To assess differences between dapagliflozin and SOC (subsequent to at least 3 months postrandomization) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at any clinical evaluation that occurs within the first 52 weeks of follow-up.
To assess differences between dapagliflozin and SOC (subsequent to 52 weeks of followup) in the achievement of clinical success in the treatment of Type II diabetes mellitus using a 4-item composite endpoint at the clinical evaluation that occurs:
- closest to 104 weeks of follow-up (allowing a window of 12 weeks);
- and separately, within the second 52 weeks of follow-up (Week 53 through Week 104).
Other objectives include evaluation of each separate item of the composite; change from baseline in HbA1c and in total body weight; the patient’s worry related to the risk of hypoglycaemic episodes; the patient’s satisfaction with treatment; and the need for antyhpertensive escalation.

Secondary Outcome(s)

Secondary end point(s): HbA1c reduction vs. baseline (= 0.5%); weight loss vs. baseline (= 2 Kg); no severe or documented hypoglycaemic events since the last (most recent) clinical assessment; no switching from or adding to the treatment to which the patient was randomized (e.g., dapagliflozin or SOC); HFS-II Worry scale score; DTSQ score; proportion of patients needing antyhypertensive escalation.

Timepoint(s) of evaluation of this end point: • At any clinical evaluation that occurs within the first 52 weeks of follow-up.
• At the clinical evaluation that occurs closest to 104 weeks of follow-up (allowing a window of 12 weeks).
• At any clinical evaluation within the second 52 weeks of follow-up (Week 53 through Week 104).

Secondary ID(s)

D1690R00009

Source(s) of Monetary Support

AstraZeneca AB

Ethics review

Status: Approved
Approval date: 27/10/2015
Contact: