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

NCT02623998 | Completed Phase 3 Results

• 1 other identifier: REMIT-Sita
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Insulin; Glargine; Metformin; Sitagliptin; Diet; Excercise; Lifestyle

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group

  Hyperglycemia relapse for primary outcome was defined as any one of: 1. Capillary glucose \>10 mmol/L on \>/=50% of readings over 1 week; 2. HbA1C \>/=6.5%; 3. use of diabetes drugs; 4. fasting plasma glucose \>/= 7.0 mmol/L; 5. 2-hour postprandial plasma glucose \>/=11.1 mmol/L on an oral glucose tolerance test.

  64 weeks of follow-up

• Number of Participants With Severe Hypoglycemic Episodes

  64 weeks of follow-up

Secondary Outcomes (4)

• Number of Participants Achieving Drug-free Diabetes Remission

  24 weeks after randomization

• Number of Participants With Drug-free Normal Glucose Tolerance

  24 weeks after randomization

• Percent Change in Weight

  Baseline and 12 weeks after randomization

• Change in Waist Circumference

  Baseline and 12 weeks after randomization

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy

Drug: insulin glargine; Drug: sitagliptin/metformin; Behavioral: lifestyle therapy

Standard Care

NO INTERVENTION

Standard glycemic care as informed by the current clinical practice guidelines

Interventions

insulin glargine DRUG

Dose is titrated to achieve fasting normoglycemia

Also known as: Lantus

Intervention

sitagliptin/metformin DRUG

Dose is titrated to 50/1000 mg bid or maximal tolerated dose

Also known as: Janumet

Intervention

lifestyle therapy BEHAVIORAL

Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Also known as: diet and exercise

Intervention

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \< 3 years;
• history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity;
• excessive alcohol consumption (\>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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

Location

Health Science Centre

Winnipeg, Manitoba, R3E 3P4, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

LMC

Markham, Ontario, Canada

Location

Univeristy of Montreal

Montreal, Quebec, Canada

Location

Related Publications (1)

• McInnes N, Hall S, Hramiak I, Sigal RJ, Goldenberg R, Gupta N, Rabasa-Lhoret R, Braga M, Woo V, Sultan F, Otto R, Smith A, Sherifali D, Liu YY, Gerstein HC; REMIT-sita Collaborative Group. 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. Diabetes Care. 2022 Jan 1;45(1):178-185. doi: 10.2337/dc21-0278.

  PMID: 34728531 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin Glargine; Sitagliptin Phosphate; Metformin; Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Diet; Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Combinations; Pharmaceutical Preparations; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Natalia McInnes
• Organization: McMaster University

natalia.mcinnes@mcmaster.ca

19055212100

Study Officials

• Natalia McInnes, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Hertzel C Gerstein, MD

  Hamilton Health Sciences Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: July 9, 2016
• Primary Completion: September 1, 2018
• Study Completion: November 30, 2019
• Last Updated: March 25, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-03

Locations

CA (6)