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Type 2 Diabetes MellitusPhase 4NCT02561130

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga

A Phase 4 study testing insulin glargine, metformin and Forxiga in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 7 sites in Canada.

Completed

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

Official record
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Trial summary

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
insulin glargine, metformin and Forxiga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
7 sitesCanada
Study dates
Dec 2015to 31 Dec 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • men and women 30-80 years of age inclusive;
  • type 2 diabetes mellitus diagnosed by a physician within 8 years prior to patient enrollment;
  • anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization;
  • HbA1C 6.5-9.5% inclusive on no hypoglycemic agents or HbA1C ≤ 8.0% on up to 2 glucose-lowering agents;
  • body mass index ≥ 23 kg/m2;
  • ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
  • ability and willingness to self-inject insulin;
  • provision of informed consent.

Who cannot join

  • current use of insulin therapy;
  • history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
  • history of end-stage renal disease or renal dysfunction as evidenced by eGFR<60 mL/min/1.73 m2 by MDRD formula;
  • history of lactic acidosis or diabetic ketoacidosis;
  • active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment;
  • history of bladder cancer or undiagnosed hematuria;
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  • history of breast cancer;
  • history of polycythemia;
  • evidence of volume depletion or hypotension (systolic blood pressure < 90 mmHg);
  • systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg;
  • diagnosed cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including:
  • any history of acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention;
  • other evidence of coronary artery disease;
  • peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA;
  • prior hospitalization for heart failure; or
  • ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
  • dependence on oxygen;
  • history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
  • history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
  • history of any major illness with a life expectancy of < 3 years;
  • history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
  • any history of excessive alcohol intake, acute or chronic;
  • currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential; reliable methods of birth control include oral contraceptive (birth control pill), hormonal injection, implant, patch, or vaginal ring, intrauterine device, barrier method (condom and spermicide), tubal ligation, partner vasectomy or abstinence;
  • known hypersensitivity to metformin, Forxiga, or insulin glargine.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Western University

    London, Ontario, N6G 2M1

  • LMC

    Toronto, Ontario, M4G 3E8

  • St. Michaels's Hospital

    Toronto, Ontario, M5C 2T2

  • Health Science Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising Forxiga, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

Read the detailed description

This is a multicentre, open-label, randomized controlled trial in 152 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C<7.3% at the 12 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.

Being tested
insulin glargine, metformin, Forxiga, Lifestyle therapy
Keywords
Diabetes, Insulin, Glargine, Metformin, Forxiga, Diet, Exercise, Lifestyle
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Motor Activity

What participants receive

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

  • insulin glargineDrug

    Also called Lantus

    Dose is titrated to achieve fasting normoglycemia

  • metforminDrug

    Dose is titrated to 1 g bid or maximal tolerated dose

  • ForxigaDrug

    Also called dapagliflozin

    Dose is titrated to 10 mg po daily or maximal tolerated dose

  • Lifestyle therapyBehavioural

    Also called diet and exercise

    Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Study groups in NCT02561130
Study groupRoleWhat they receive
InterventionExperimentalDrug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise
Receives: Drug: insulin glargine; Drug: metformin; Drug: Forxiga; Behavioral: Lifestyle therapy
Standard CareNo interventionStandard glycemic care as informed by the current clinical practice guidelines

What is being measured

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

  1. Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group

    Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.

    Measured: 24 weeks after randomization

Secondary outcomes (8)

  1. Number of Participants Achieving Drug-free Diabetes Remission

    Drug-free diabetes remission is defined as HbA1C < 6.5 % off glucose-lowering agents for at least 12 weeks.

    Measured: 64 weeks after randomization

  2. Number of Participants Achieving Drug-free HbA1C < 6.0%

    Drug-free complete diabetes remission is defined as HbA1C < 6.0 % off glucose-lowering agents for at least 12 weeks.

    Measured: 24 weeks after randomization

  3. Number of Participants Achieving Diabetes Relapse Without Overt Hyperglycemia Off Diabetes Drugs

    Diabetes relapse without overt hyperglycemia is defined as HbA1C 6.5-6.9% off glucose-lowering agents for at least 12 weeks.

    Measured: 24 weeks

  4. Glycated Hemoglobin (HbA1C)

    Expressed in Diabetes Control and Complications Trial (DCCT) units

    Measured: 12 weeks after randomization

  5. Number of Participants With Non-severe Symptomatic Hypoglycemic Episodes

    Symptomatic hypoglycemic episode is defined as an event with clinical symptoms consistent with hypoglycemia.

    Measured: During 64 weeks of follow-up

  6. Percentage of Weight Loss From Baseline

    (Weight at randomization - weight at 12 weeks)/(weight at randomization)

    Measured: 12 weeks after randomization

  7. Change in Waist Circumference From Baseline

    (Waist circumference at 12 weeks - waist circumference at randomization)

    Measured: 12 weeks after randomization

  8. Number of Participants With Severe Hypoglycemic Episodes

    Severe hypoglycemic episode is defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following: (i) the event was associated with a documented self-measured or laboratory plasma glucose level </= 2.0 mmol/L or (ii) the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

    Measured: During 64 weeks of follow-up

Timeline

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

  1. First posted25 Sep 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2017
  4. Study completion31 Dec 2018

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
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02561130
Sponsor's protocol ID
REMIT-Dapa
Status last verified
Nov 2020
First submitted
16 Sep 2015
Last updated
24 Nov 2020
Data monitoring committee
No

Publications

  • McInnes N, Hall S, Sultan F, Aronson R, Hramiak I, Harris S, Sigal RJ, Woo V, Liu YY, Gerstein HC. Remission of Type 2 Diabetes Following a Short-term Intervention With Insulin Glargine, Metformin, and Dapagliflozin. J Clin Endocrinol Metab. 2020 Aug 1;105(8):dgaa248. doi: 10.1210/clinem/dgaa248.

    PubMed 32403130

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin glargine, metformin and Forxiga in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 7 sites in Canada.

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 8 inclusion and 24 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. 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. 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?

Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group (time frame: 24 weeks after randomization). 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 NCT02561130, 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 Nov 2020.

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