Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
3 other identifiers
interventional
83
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 type-2-diabetes-mellitus
Started Jan 2011
Longer than P75 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 21, 2020
CompletedMay 21, 2020
May 1, 2020
4.1 years
August 11, 2010
April 6, 2020
May 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Normoglycemia on Therapy
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.
(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.
(1) 20 weeks and (2) 28 weeks
Percentage of Participants With Normal Fasting Plasma Glucose
52 weeks
Change in Fasting Plasma Glucose From Baseline
Baseline and 52 weeks
HbA1C
8, 20, 28 and 52 weeks
Change in Weight From Baseline
Baseline, 8, 20, 28 and 52 weeks
- +2 more secondary outcomes
Study Arms (3)
Group 1 (short)
EXPERIMENTALGroup 2 (long)
EXPERIMENTALStandard care
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
- ability and willingness to perform self-monitoring of capillary blood glucose (SMBG)
- ability and willingness to self-inject insulin
- provision of informed consent.
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University Medical Centre, Diabetes Care and Research Program
Hamilton, Ontario, L8N 3Z5, Canada
Related Publications (1)
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.
PMID: 28324049RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Natalia McInnes (nee Yakubovich)
- Organization
- McMaster University
Study Officials
- PRINCIPAL INVESTIGATOR
Hertzel Gerstein, MD
Population Health Research Institute
- PRINCIPAL INVESTIGATOR
Natalia McInnes (nee Yakubovich), MD
Population Health Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Endocrinology and Metabolism, McMaster University
Study Record Dates
First Submitted
August 11, 2010
First Posted
August 13, 2010
Study Start
January 1, 2011
Primary Completion
February 1, 2015
Study Completion
September 1, 2015
Last Updated
May 21, 2020
Results First Posted
May 21, 2020
Record last verified: 2020-05