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

NCT ID: NCT01181674

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (short)

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

sc injection

metformin

Intervention Type: DRUG

oral administration

acarbose

Intervention Type: DRUG

oral administration

lifestyle therapy

Intervention Type: BEHAVIORAL

diet and exercise

Group 2 (long)

Group Type: EXPERIMENTAL

insulin glargine

Intervention Type: DRUG

sc injection

metformin

Intervention Type: DRUG

oral administration

acarbose

Intervention Type: DRUG

oral administration

lifestyle therapy

Intervention Type: BEHAVIORAL

diet and exercise

Standard care

Group Type: OTHER

Standard glycemic care

Intervention Type: OTHER

as informed by the current clinical practice guidelines

Interventions

insulin glargine

sc injection

Intervention Type: DRUG

metformin

oral administration

Intervention Type: DRUG

acarbose

oral administration

Intervention Type: DRUG

lifestyle therapy

diet and exercise

Intervention Type: BEHAVIORAL

insulin glargine

sc injection

Intervention Type: DRUG

metformin

oral administration

Intervention Type: DRUG

acarbose

oral administration

Intervention Type: DRUG

lifestyle therapy

diet and exercise

Intervention Type: BEHAVIORAL

Standard glycemic care

as informed by the current clinical practice guidelines

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr. Hertzel Gerstein

Director, Division of Endocrinology and Metabolism, McMaster University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hertzel Gerstein, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Natalia McInnes (nee Yakubovich), MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

McMaster University Medical Centre, Diabetes Care and Research Program

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 28324049 (View on PubMed)

Other Identifiers

Control # 139433, 143584

Identifier Type: OTHER

Identifier Source: secondary_id

10-346

Identifier Type: OTHER

Identifier Source: secondary_id

REMIT Pilot

Identifier Type: -

Identifier Source: org_study_id