Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: insulin glargine Drug: metformin Drug: acarbose Behavioral: lifestyle therapy Drug: insulin glargine Drug: metformin Drug: acarbose Behavioral: lifestyle therapy Other: Standard glycemic care |
Phase | Phase 4 |
Sponsor | Population Health Research Institute |
Responsible Party | Population Health Research Institute |
ClinicalTrials.gov Identifier | NCT01181674 |
First Received | August 11, 2010 |
Last Updated | June 7, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | August 11, 2010 |
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Last Updated Date | June 7, 2012 |
Start Date | January 2011 |
Estimated Primary Completion Date | January 2014 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial) |
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Official Title | Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial |
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. |
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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: insulin glargine sc injection Drug: metformin oral administration Drug: acarbose oral administration Behavioral: lifestyle therapy diet and exercise Drug: insulin glargine sc injection Drug: metformin oral administration Drug: acarbose oral administration Behavioral: lifestyle therapy diet and exercise Other: Standard glycemic care as informed by the current clinical practice guidelines |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 126 |
Estimated Completion Date | January 2014 |
Estimated Primary Completion Date | January 2014 |
Eligibility Criteria | Inclusion Criteria: 1. men and women 30-80 years of age inclusive 2. type 2 diabetes mellitus diagnosed by a physician within 3 years prior to patient enrollment 3. anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization 4. HbA1C 6.5-8% inclusive on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 agent or on half-maximal doses of 2 agents 5. body mass index ≥ 23 kg/m2 6. 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 7. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG) 8. ability and willingness to self-inject insulin 9. provision of informed consent. Exclusion Criteria: 1. current use of insulin therapy 2. history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance 3. renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l 4. history of lactic acidosis or diabetic ketoacidosis 5. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment 6. history of inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction 7. 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 8. pulmonary disease with dependence on oxygen 9. history of any disease requiring intermittent or continuous systemic glucocorticoid treatment 10. history of any major illness with a life expectancy of <3 years 11. history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity 12. any history of excessive alcohol intake, acute or chronic 13. known hypersensitivity to metformin, acarbose, or insulin glargine. |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Hertzel Gerstein, MD gerstein@mcmaster.ca |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01181674 |
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Other Study ID Numbers | REMIT Pilot |
Has Data Monitoring Committee | No |
Information Provided By | Population Health Research Institute |
Study Sponsor | Population Health Research Institute |
Collaborators | Hamilton Health Sciences Corporation |
Investigators | Principal Investigator: Hertzel Gerstein, MD Population Health Research InstitutePrincipal Investigator: Natalia Yakubovich, MD Population Health Research Institute |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
McMaster University Medical Centre, Diabetes Care and Research Program | Hamilton, Ontario, Canada, L8N 3Z5 Contact: Ada Smith | 905-525-914022205Recruiting |
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