Overview

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

Status:
Completed
Trial end date:
2019-11-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether in patients with early type 2 diabetes,a short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Population Health Research Institute
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

1. men and women 30-80 years of age inclusive;

2. type 2 diabetes mellitus diagnosed by a physician within 5 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 ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral 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);
ability and willingness to self-inject insulin;

8. provision of informed consent.

Exclusion Criteria:

1. current use of insulin;

2. history of hypoglycemia unawareness; history of severe hypoglycemia requiring
assistance within the last 5 years;

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 pancreatitis;

7. cardiovascular disease including any of: a) systolic blood pressure > 180 mmHg or
diastolic blood pressure > 105 mmHg; b) peripheral vascular disease; c) left bundle
branch block or second or third degree AV block; d) tachyarrhythmias or
bradyarrhythmias with uncontrolled ventricular rate; e) stenotic valvular heart
disease; f) cardiomyopathy; g) history of heart failure; h) history of aortic
dissection; i) documented history of angina or coronary artery disease; j) history of
stroke or transient ischemic attack;

8. history of any disease requiring continuous systemic glucocorticoid treatment;

9. history of any major illness with a life expectancy of < 3 years;

10. history of injury or any other condition that significantly limits participant's
ability to achieve moderate levels of physical activity;

11. excessive alcohol consumption (>14 alcoholic drinks per week in men and >7 alcoholic
drinks per week in women);

12. known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.