Phase 3
Completed N=102
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)
Source: ClinicalTrials.gov NCT02623998 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group — 41; 48 Participants
◆ Published Evidence
Established
22citations · ~6 / year
Remission of Type 2 Diabetes Following a Short-term Intensive Intervention With Insulin Glargine, Sitagliptin, and Metformin: Results of an Open-label Randomized Parallel-Design Trial.
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.
Linked Publications
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Remission of Type 2 Diabetes Following a Short-term Intensive Intervention With Insulin Glargine, Sitagliptin, and Metformin: Results of an Open-label Randomized Parallel-Design Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group |
41; 48 | — |
| PRIMARY Number of Participants With Severe Hypoglycemic Episodes |
0; 0 | — |
| SECONDARY Number of Participants Achieving Drug-free Diabetes Remission |
8; 4 | — |
| SECONDARY Number of Participants With Drug-free Normal Glucose Tolerance |
3; 1 | — |
| SECONDARY Percent Change in Weight |
-2.1; -1.4 | — |
| SECONDARY Change in Waist Circumference |
-2.3; -1.8 | — |
Eligibility Criteria
Inclusion Criteria
- men and women 30-80 years of age inclusive;
- type 2 diabetes mellitus diagnosed by a physician within 5 years prior to patient enrollment;
- anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization;
- HbA1C ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral agent or on half-maximal doses of 2 agents;
- body mass index ≥ 23 kg/m2;
- 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;
- ability and willingness to perform self-monitoring of capillary blood glucose (SMBG); ability and willingness to self-inject insulin;
- provision of informed consent.
Exclusion Criteria
- current use of insulin;
- history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years;
- renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l;
- history of lactic acidosis or diabetic ketoacidosis;
- active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment;
- history of pancreatitis;
- 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;
- history of any disease requiring continuous systemic glucocorticoid treatment;
- history of any major illness with a life expectancy of 14 alcoholic drinks per week in men and >7 alcoholic drinks per week in women);
- known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.
Data sourced from ClinicalTrials.gov (NCT02623998) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.