Clinical trial NCT01181674: Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
Official title: Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Insulin
Glargine
Metformin
Acarbose
Diet
Exercise
Lifestyle
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2010-08-13
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 ≤ 8.5% 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.

Primary outcomes:
measure: Normoglycemia on Therapy
timeFrame: (1) 8 weeks and (2) 16 weeks
Secondary outcomes:
measure: 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.
timeFrame: (1) 20 weeks and (2) 28 weeks
measure: Percentage of Participants With Normal Fasting Plasma Glucose
timeFrame: 52 weeks
measure: Change in Fasting Plasma Glucose From Baseline
timeFrame: Baseline and 52 weeks
measure: HbA1C
timeFrame: 8, 20, 28 and 52 weeks
measure: Change in Weight From Baseline
timeFrame: Baseline, 8, 20, 28 and 52 weeks
measure: Number of Participants With Symptomatic Hypoglycemic Episodes
timeFrame: 52 weeks
measure: Number of Participants With Severe Hypoglycemic Episodes
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre, Diabetes Care and Research Program
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Hertzel Gerstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Natalia McInnes (nee Yakubovich), MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.