Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Population Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Dr. Hertzel Gerstein, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01181674
First received: August 11, 2010
Last updated: June 7, 2012
Last verified: June 2012
  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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: insulin glargine
Drug: metformin
Drug: acarbose
Behavioral: lifestyle therapy
Other: Standard glycemic care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Proportion of participants achieving normoglycemia in the experimental group 1 compared to the control group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants achieving normoglycemia in the experimental group 2 compared to the control group [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with normal glucose tolerance [ Time Frame: 20 and 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with normal fasting plasma glucose [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: 8, 20, 28 and 52 weeks ] [ Designated as safety issue: No ]
  • Change in weight from baseline [ Time Frame: Baseline, 8, 20, 28 and 52 weeks ] [ Designated as safety issue: No ]
  • Rate of symptomatic hypoglycemic episodes [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
  • Rate of severe hypoglycemic episodes [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 126
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (short) Drug: insulin glargine
sc injection
Drug: metformin
oral administration
Drug: acarbose
oral administration
Behavioral: lifestyle therapy
diet and exercise
Experimental: Group 2 (long) Drug: insulin glargine
sc injection
Drug: metformin
oral administration
Drug: acarbose
oral administration
Behavioral: lifestyle therapy
diet and exercise
Standard care Other: Standard glycemic care
as informed by the current clinical practice guidelines

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181674

Contacts
Contact: Hertzel Gerstein, MD gerstein@mcmaster.ca

Locations
Canada, Ontario
McMaster University Medical Centre, Diabetes Care and Research Program Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Ada Smith    905-525-9140 ext 22205      
Sponsors and Collaborators
Population Health Research Institute
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Hertzel Gerstein, MD Population Health Research Institute
Principal Investigator: Natalia Yakubovich, MD Population Health Research Institute
  More Information

No publications provided

Responsible Party: Dr. Hertzel Gerstein, Director, Division of Endocrinology and Metabolism, McMaster University, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01181674     History of Changes
Other Study ID Numbers: REMIT Pilot, Control # 139433, 143584, 10-346
Study First Received: August 11, 2010
Last Updated: June 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by Population Health Research Institute:
Diabetes
Insulin
Glargine
Metformin
Acarbose
Diet
Exercise
Lifestyle

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Metformin
Acarbose
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014