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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: insulin glargine
Drug: metformin
Drug: acarbose
Behavioral: lifestyle therapy
Drug: insulin glargine
Drug: metformin
Drug: acarbose
Behavioral: lifestyle therapy
Other: Standard glycemic care
PhasePhase 4
SponsorPopulation Health Research Institute
Responsible PartyPopulation Health Research Institute
ClinicalTrials.gov IdentifierNCT01181674
First ReceivedAugust 11, 2010
Last UpdatedJune 7, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateAugust 11, 2010
Last Updated DateJune 7, 2012
Start DateJanuary 2011
Estimated Primary Completion DateJanuary 2014
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleRemission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
Official TitleRemission 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: 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)
  • Experimental: Group 1 (short)
  • Experimental: Group 2 (long)
  • Other: Standard care

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment126
Estimated Completion DateJanuary 2014
Estimated Primary Completion DateJanuary 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.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsContact: Hertzel Gerstein, MD
gerstein@mcmaster.ca
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT01181674
Other Study ID NumbersREMIT Pilot
Has Data Monitoring CommitteeNo
Information Provided ByPopulation Health Research Institute
Study SponsorPopulation Health Research Institute
CollaboratorsHamilton Health Sciences Corporation
Investigators Principal Investigator: Hertzel Gerstein, MD Population Health Research InstitutePrincipal Investigator: Natalia Yakubovich, MD Population Health Research Institute
Verification DateJune 2012

Locations[ + expand ][ + ]

McMaster University Medical Centre, Diabetes Care and Research Program
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Ada Smith | 905-525-914022205
Recruiting