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Type 2 Diabetes MellitusPhase 3NCT02623998

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

A Phase 3 study testing insulin glargine, sitagliptin/metformin and lifestyle therapy in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 6 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 of sitagliptin, 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, sitagliptin/metformin and lifestyle therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
6 sitesCanada
Study dates
9 Jul 2016to 30 Nov 2019
Phase
Phase 3
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 5 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 ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral agent or on half-maximal doses of 2 agents;
  • body mass index ≥ 23 kg/m2;
  • a negative pregnancy test and an agreement to use a reliable method of birth control for the duration of the trial in all females with childbearing potential;
  • 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;
  • history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years;
  • renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l;
  • 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 pancreatitis;
Show all 12Show fewer
  • cardiovascular disease including any of: a) systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg; b) peripheral vascular disease; c) left bundle branch block or second or third degree AV block; d) tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate; e) stenotic valvular heart disease; f) cardiomyopathy; g) history of heart failure; h) history of aortic dissection; i) documented history of angina or coronary artery disease; j) history of stroke or transient ischemic attack;
  • history of any disease requiring continuous systemic glucocorticoid treatment;
  • 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;
  • excessive alcohol consumption (>14 alcoholic drinks per week in men and >7 alcoholic drinks per week in women);
  • known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • University of Calgary

    Calgary, Alberta, T2T 5C7

  • McMaster University

    Hamilton, Ontario

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • LMC

    Markham, Ontario

  • Univeristy of Montreal

    Montreal, Quebec

  • Health Science Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

About this study

Official title: An Open-label, Randomized, Parallel Design Trial to Compare the Efficacy of a Sitagliptin-based Metabolic Intervention Versus Standard Diabetes Therapy in Inducing Remission of Type 2 Diabetes

The purpose of the study is to determine whether in patients with early type 2 diabetes,a short-term intensive metabolic intervention comprising of sitagliptin, 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 100 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with sitagliptin, metformin, insulin glargine and lifestyle therapy, or (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 meet criteria for hyperglycemic relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines

Being tested
insulin glargine, sitagliptin/metformin, lifestyle therapy
Keywords
Diabetes, Insulin, Glargine, Metformin, Sitagliptin, Diet, Excercise, Lifestyle
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance

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

  • sitagliptin/metforminDrug

    Also called Janumet

    Dose is titrated to 50/1000 mg bid 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 NCT02623998
Study groupRoleWhat they receive
InterventionExperimentalDrug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
Receives: Drug: insulin glargine; Drug: sitagliptin/metformin; 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 With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group

    Hyperglycemia relapse for primary outcome was defined as any one of:

    1. Capillary glucose >10 mmol/L on >/=50% of readings over 1 week;
    2. HbA1C >/=6.5%;
    3. use of diabetes drugs;
    4. fasting plasma glucose >/= 7.0 mmol/L;
    5. 2-hour postprandial plasma glucose >/=11.1 mmol/L on an oral glucose tolerance test.

    Measured: 64 weeks of follow-up

  2. Number of Participants With Severe Hypoglycemic Episodes

    Measured: 64 weeks of follow-up

Secondary outcomes (4)

  1. Number of Participants Achieving Drug-free Diabetes Remission

    Diabetes remission is defined as absence of hyperglycemia relapse

    Measured: 24 weeks after randomization

  2. Number of Participants With Drug-free Normal Glucose Tolerance

    Normal glucose tolerance is defined as a FPG<6.1 mmol/L and a 2-hour plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test

    Measured: 24 weeks after randomization

  3. Percent Change in Weight

    Measured: Baseline and 12 weeks after randomization

  4. Change in Waist Circumference

    Measured: Baseline and 12 weeks after randomization

Timeline

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

  1. First posted8 Dec 2015 (estimated)
  2. Study start9 Jul 2016
  3. Primary completion1 Sep 2018
  4. Study completion30 Nov 2019

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623998
Sponsor's protocol ID
REMIT-Sita
Status last verified
Mar 2022
First submitted
4 Dec 2015
Last updated
25 Mar 2022
Data monitoring committee
No

Publications

  • McInnes N, Hall S, Hramiak I, Sigal RJ, Goldenberg R, Gupta N, Rabasa-Lhoret R, Braga M, Woo V, Sultan F, Otto R, Smith A, Sherifali D, Liu YY, Gerstein HC; REMIT-sita Collaborative Group. Remission of Type 2 Diabetes Following a Short-term Intensive Intervention With Insulin Glargine, Sitagliptin, and Metformin: Results of an Open-label Randomized Parallel-Design Trial. Diabetes Care. 2022 Jan 1;45(1):178-185. doi: 10.2337/dc21-0278.

    PubMed 34728531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin glargine, sitagliptin/metformin and lifestyle therapy in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 6 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 12 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Mar 2022). 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 With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group (time frame: 64 weeks of follow-up). The study lists 2 primary outcomes in all. 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 NCT02623998, 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 25 Mar 2022.

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