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

Population Health Research Institute (PHRI)

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Standard glycemic care; Drug: metformin; Drug: insulin glargine; Behavioral: lifestyle therapy; Drug: acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT01181674

10-346 (Other Identifier)

Control # 139433, 143584 (Other Identifier)

REMIT Pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

83 participants in 3 patient groups

Group 1 (short)

Experimental group

Treatment:

Behavioral: lifestyle therapy

Drug: acarbose

Drug: insulin glargine

Drug: metformin

Drug: insulin glargine

Drug: acarbose

Behavioral: lifestyle therapy

Drug: metformin

Group 2 (long)

Experimental group

Treatment:

Behavioral: lifestyle therapy

Drug: acarbose

Drug: insulin glargine

Drug: metformin

Drug: insulin glargine

Drug: acarbose

Behavioral: lifestyle therapy

Drug: metformin

Standard care

Other group

Treatment:

Other: Standard glycemic care