AzTrials
AzTrials

Type 2 DiabetesPhase 4READNCT04004793

Remission of Type 2 Diabetes With Dapagliflozin (READ Trial)

A Phase 4 study testing Intensive lifestyle intervention and Dapagliflozin 10 MG Oral Tablet in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the effect of dapagliflozin add-on intensive lifestyle intervention for remission of type 2 diabetes in obese patients with Type 2 Diabetes Mellitus. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Intensive lifestyle intervention and Dapagliflozin 10 MG Oral Tablet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
328 participants
Where
1 siteChina
Study dates
12 Jun 2020to 31 Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged 20-70 years old who had a BMI ≥25 kg/m2.
  • Subjects had been diagnosed with type 2 diabetes within 6 years
  • HbA1C ≥6.5% and ≤10.0% at screening if on treatment with metformin alone or without antidiabetic agents, or HbA1C <6.5% at screening if on metformin treatment alone
  • Able and willing to provide written informed consent and to comply with the study

Who cannot join

  • Patients have a history of myocardial infarction, unstable angina, cardiac surgery or revascularization (coronary artery bypass graft/percutaneous transluminal coronary angioplasty), or congestive heart failure New York Heart Association Class III or IV.
  • Current insulin use.
  • Weight loss of more than 5kg within the past 6 months.
  • Women who are pregnant or plan to become pregnant.
  • Diagnosis or history of acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state, or diabetes insipidus within 30 days.
  • Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
Show all 18Show fewer
  • Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial (involving an investigational drug and /or follow-up).
  • Patients with clinically apparent hepatobiliary disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST > 3x upper limit of normal (ULN), or serum total bilirubin (TB) >34.2 μmol/L (>2 mg/dL).
  • Patients with severe renal impairment or end-stage renal disease (eGFR< 45 mL/min/1.73 m2).
  • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
  • Malignancy within 5 years of the enrollment visit.
  • Known immunocompromised status, including but not limited to, individuals who had undergone organ transplantation or acquired immunodeficiency syndrome (AIDS).
  • History of bone fracture secondary to diagnosed severe osteoporosis.
  • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.
  • Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, or phendimetrazine within 30 days of enrollment visit.
  • Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia).
  • Administration of any other investigational drug within 30 days of planned enrollment to this study, or within 5 half-life periods of other investigational drugs.
  • Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Medical college of

    Shanghai, 200032

Other trials in China

About this study

Official title: Effect of Dapagliflozin for Remission of Type 2 Diabetes Mellitus: A Multicenter, Randomized, Placebo-Controlled Trial

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the effect of dapagliflozin add-on intensive lifestyle intervention for remission of type 2 diabetes in obese patients with Type 2 Diabetes Mellitus. The study consists of a 12-months treatment period (in which they will receive either Dapagliflozin plus intensive lifestyle intervention or placebo plus intensive lifestyle intervention in addition to the background therapy), and a 2-month follow-up period after treatment period.

Read the detailed description

Diabetes remission is an important issue which has not been well studied. Some studies showed that bariatric surgery and intensive lifestyle intervention could lead to remission in diabetic patients. Our present study aims to assess the effect of dapagliflozin add-on intensive lifestyle intervention on remission of type 2 diabetes in obese patients with type 2 diabetes. This is a multicenter, randomized, double-blind, placebo-controlled study. The study consists of a 12-months treatment period (in which subjects will receive either dapagliflozin plus intensive lifestyle intervention or placebo plus intensive lifestyle intervention in addition to the background therapy), and a 2-month follow-up period after treatment period.

Conditions
Type 2 Diabetes
Being tested
Intensive lifestyle intervention, Dapagliflozin 10 MG Oral Tablet, Placebo Oral Tablet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive lifestyle interventionBehavioural

    Participants were will be asked to follow a weight management programme, in accordance with the American Diabetes Association guidelines. Weight loss will be induced with a diet replacement phase using an energy restriction diet (energy deficit by 500~750 kcal/day) for 3 months, with <35% as fat, >15% as protein. The minimum energy intake is 1200kcal/day for men and 1000kcal/day for women.. Additionally, participants were encouraged to increase physical exercise (≥150 minutes of brisk walking every week or ≥10000 steps per day).

  • Dapagliflozin 10 MG Oral TabletDrug

    The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.

  • Placebo Oral TabletDrug

    The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.

Study groups in NCT04004793
Study groupRoleWhat they receive
Dapagliflozin plus intensive lifestyle interventionExperimentalThe treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
Receives: Behavioral: Intensive lifestyle intervention; Drug: Dapagliflozin 10 MG Oral Tablet
Placebo plus intensive lifestyle interventionPlacebo comparatorThe treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
Receives: Behavioral: Intensive lifestyle intervention; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of patients with diabetes remission

    Diabetes remission is defined as a HbA1c<6.5% and a fasting glucose level of <7.0 mmol/l in the absence of all antidiabetic medication for at least 2 months

    Measured: During the 12-month intervention

Secondary outcomes (10)

  1. Proportion of patients with diabetes remission

    Measured: during the 12-month intervention

  2. Net change in body weight

    Measured: during both 12 and 14 months

  3. Net change in waist circumference

    Measured: during both 12 and 14 months

  4. Net change in HOMA-IR

    Measured: during both 12 and 14 months

  5. Net change in serum lipids

    Measured: during both 12 and 14 months

  6. Net change in HbA1c

    Measured: during both 12 and 14 months

  7. Net change in body fat

    Measured: during both 12 and 14 months

  8. Net change in SBP

    Measured: during both 12 and 14 months

  9. Net change in Serum Creatine

    Measured: during both 12 and 14 months

  10. Net change in Albuminuria

    Measured: during both 12 and 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start12 Jun 2020
  3. Primary completion31 Jan 2023
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04004793
Sponsor's protocol ID
ZSE-201901
Acronym
READ
Status last verified
Jul 2024
First submitted
28 Jun 2019
Last updated
24 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu Y, Chen Y, Ma J, Lin J, Liu C, Li X, Xu Y, Kuang H, Shi L, Xue Y, Feng B, Zhu D, Wang G, Yang J, Xiao X, Yu X, Zhou J, Bao Y, Su Q, Lyu M, Li X, Zhang H, Li X. Dapagliflozin plus calorie restriction for remission of type 2 diabetes: multicentre, double blind, randomised, placebo controlled trial. BMJ. 2025 Jan 22;388:e081820. doi: 10.1136/bmj-2024-081820.

    PubMed 39843169

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intensive lifestyle intervention and Dapagliflozin 10 MG Oral Tablet in people with Type 2 Diabetes, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of patients with diabetes remission (time frame: During the 12-month intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004793, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in