Type 2 Diabetes MellitusPhase 4NCT01181674
Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
A Phase 4 study testing insulin glargine, metformin and acarbose in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 1 site in Canada.
Trial summary
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care. 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 acarbose
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Sep 2015
- 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 3 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 ≤ 8.5% on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 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
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- 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
- 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 inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction
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- cardiovascular disease including any of:
- systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- peripheral vascular disease
- left bundle branch block or third degree AV block
- tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate
- stenotic valvular heart disease
- cardiomyopathy
- history of heart failure
- history of aortic dissection
- documented history of angina or coronary artery disease
- history of stroke or transient ischemic attack
- pulmonary disease with dependence on oxygen
- history of any disease requiring intermittent or 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
- any history of excessive alcohol intake, acute or chronic
- known hypersensitivity to metformin, acarbose, or insulin glargine.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University Medical Centre, Diabetes Care and Research Program
Hamilton, Ontario, L8N 3Z5
About this study
Official title: Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.
Read the detailed description
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin glargine, metformin, acarbose, lifestyle therapy, Standard glycemic care
- Keywords
- Diabetes, Insulin, Glargine, Metformin, Acarbose, 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
sc injection
metforminDrug
oral administration
acarboseDrug
oral administration
lifestyle therapyBehavioural
diet and exercise
insulin glargineDrug
sc injection
metforminDrug
oral administration
acarboseDrug
oral administration
lifestyle therapyBehavioural
diet and exercise
Standard glycemic careOther
as informed by the current clinical practice guidelines
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (short) | Experimental | Not described Receives: Drug: insulin glargine; Drug: metformin; Drug: acarbose; Behavioral: lifestyle therapy |
| Group 2 (long) | Experimental | Not described Receives: Drug: insulin glargine; Drug: metformin; Drug: acarbose; Behavioral: lifestyle therapy |
| Standard care | Other | Not described Receives: Other: Standard glycemic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normoglycemia on Therapy
- Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group.
- Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group.
Normoglycemia on therapy is defined as a mean fasting capillary blood glucose </=5.4 mmol/L and a mean 2-hour pc blood glucose </=6.8 mmol/L on 2 seven-point glucose profiles.
Measured: (1) 8 weeks and (2) 16 weeks
Secondary outcomes (7)
1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs.
Measured: (1) 20 weeks and (2) 28 weeks
Percentage of Participants With Normal Fasting Plasma Glucose
Normal fasting plasma glucose is defined as <6.1 mmol/L.
Measured: 52 weeks
Change in Fasting Plasma Glucose From Baseline
Measured: Baseline and 52 weeks
HbA1C
Measured: 8, 20, 28 and 52 weeks
Change in Weight From Baseline
Measured: Baseline, 8, 20, 28 and 52 weeks
Number of Participants With Symptomatic Hypoglycemic Episodes
Measured: 52 weeks
Number of Participants With Severe Hypoglycemic Episodes
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Dr. Hertzel Gerstein, Population Health Research Institute
- Investigators
- Hertzel Gerstein, MD, Principal investigator, Population Health Research InstituteNatalia McInnes (nee Yakubovich), MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181674
- Sponsor's protocol ID
- REMIT Pilot
- Other IDs
- Control # 139433, 143584, 10-346
- Status last verified
- May 2020
- First submitted
- 11 Aug 2010
- Last updated
- 21 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McInnes N, Smith A, Otto R, Vandermey J, Punthakee Z, Sherifali D, Balasubramanian K, Hall S, Gerstein HC. Piloting a Remission Strategy in Type 2 Diabetes: Results of a Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1596-1605. doi: 10.1210/jc.2016-3373.
PubMed 28324049
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT01181674
- Acronym / sponsor ID
- REMIT Pilot
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Insulin, Glargine, Metformin, Acarbose, Diet, Exercise, Lifestyle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- Jan 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Posted 21 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.
Detailed description
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (short) | Experimental | Drug: insulin glargine, Drug: metformin, Drug: acarbose, Behavioral: lifestyle therapy |
| Group 2 (long) | Experimental | Drug: insulin glargine, Drug: metformin, Drug: acarbose, Behavioral: lifestyle therapy |
| Standard care | Other | Other: Standard glycemic care |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- men and women 30-80 years of age inclusive
- type 2 diabetes mellitus diagnosed by a physician within 3 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 ≤ 8.5% on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 agent or on half-maximal doses of 2 agents
- body mass index ≥ 23 kg/m2
Key exclusion criteria (23 listed)
- current use of insulin therapy
- history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin glarginesc injection | Drug | Group 1 (short) |
| metforminoral administration | Drug | Group 1 (short) |
| acarboseoral administration | Drug | Group 1 (short) |
| lifestyle therapydiet and exercise | Behavioural | Group 1 (short) |
| insulin glarginesc injection | Drug | Group 2 (long) |
| metforminoral administration | Drug | Group 2 (long) |
| acarboseoral administration | Drug | Group 2 (long) |
| lifestyle therapydiet and exercise | Behavioural | Group 2 (long) |
| Standard glycemic careas informed by the current clinical practice guidelines | Other | Standard care |
Primary outcome
Normoglycemia on Therapy
Time frame: (1) 8 weeks and (2) 16 weeks
1. Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group. 2. Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group. Normoglycemia on therapy is defined as a mean fasting capillary blood glucose </=5.4 mmol/L and a mean 2-hour pc blood glucose </=6.8 mmol/L on 2 seven-point glucose profiles.
7 secondary outcomes
1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
Time frame: (1) 20 weeks and (2) 28 weeks
Percentage of Participants With Normal Fasting Plasma Glucose
Time frame: 52 weeks
Change in Fasting Plasma Glucose From Baseline
Time frame: Baseline and 52 weeks
HbA1C
Time frame: 8, 20, 28 and 52 weeks
Change in Weight From Baseline
Time frame: Baseline, 8, 20, 28 and 52 weeks
Number of Participants With Symptomatic Hypoglycemic Episodes
Time frame: 52 weeks
Number of Participants With Severe Hypoglycemic Episodes
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28324049McInnes N, Smith A, Otto R, Vandermey J, Punthakee Z, Sherifali D, Balasubramanian K, Hall S, Gerstein HC. Piloting a Remission Strategy in Type 2 Diabetes: Results of a Randomized Controlled Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1596-1605. doi: 10.1210/jc.2016-3373.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hertzel Gerstein, MD principal investigator
Population Health Research Institute
Natalia McInnes (nee Yakubovich), MD principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin glargine, metformin and acarbose in people with Type 2 Diabetes Mellitus, run by Population Health Research Institute at 1 site 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 9 inclusion and 23 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 21 May 2020. 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 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 21 May 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?
Normoglycemia on Therapy (time frame: (1) 8 weeks and (2) 16 weeks). 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 NCT01181674, 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 21 May 2020.