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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

insulin glargine

metformin

acarbose

lifestyle therapy

insulin glargine

metformin

acarbose

lifestyle therapy

Standard glycemic care

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Insulin, Glargine, Metformin, Acarbose, Diet, Exercise, Lifestyle

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

men and women 30-80 years of age inclusive
type 2 diabetes mellitus diagnosed by a physician within 3 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 ≤ 8.5% on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 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 therapy
history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance
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 inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction
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
pulmonary disease with dependence on oxygen
history of any disease requiring intermittent or 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
any history of excessive alcohol intake, acute or chronic
known hypersensitivity to metformin, acarbose, or insulin glargine.

Sites / Locations

McMaster University Medical Centre, Diabetes Care and Research Program

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Group 1 (short)

Group 2 (long)

Standard care

Arm Description

Outcomes

Primary Outcome Measures

Normoglycemia on Therapy

Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group. Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group. Normoglycemia on therapy is defined as a mean fasting capillary blood glucose </=5.4 mmol/L and a mean 2-hour pc blood glucose </=6.8 mmol/L on 2 seven-point glucose profiles.

Secondary Outcome Measures

1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.

Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs.

Percentage of Participants With Normal Fasting Plasma Glucose

Normal fasting plasma glucose is defined as <6.1 mmol/L.

Change in Fasting Plasma Glucose From Baseline

HbA1C

Change in Weight From Baseline

Number of Participants With Symptomatic Hypoglycemic Episodes

Number of Participants With Severe Hypoglycemic Episodes

Full Information

NCT ID

NCT01181674

First Posted

August 11, 2010

Last Updated

May 10, 2020

Sponsor

Population Health Research Institute

Collaborators

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01181674

Brief Title

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

Official Title

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Population Health Research Institute

Collaborators

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Diabetes, Insulin, Glargine, Metformin, Acarbose, Diet, Exercise, Lifestyle

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (short)

Arm Type

Experimental

Arm Title

Group 2 (long)

Arm Type

Experimental

Arm Title

Standard care

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

sc injection

Intervention Type

Drug

Intervention Name(s)

metformin

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

acarbose

Intervention Description

oral administration

Intervention Type

Behavioral

Intervention Name(s)

lifestyle therapy

Intervention Description

diet and exercise

Intervention Type

Drug

Intervention Name(s)

insulin glargine

Intervention Description

sc injection

Intervention Type

Drug

Intervention Name(s)

metformin

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

acarbose

Intervention Description

oral administration

Intervention Type

Behavioral

Intervention Name(s)

lifestyle therapy

Intervention Description

diet and exercise

Intervention Type

Other

Intervention Name(s)

Standard glycemic care

Intervention Description

as informed by the current clinical practice guidelines

Primary Outcome Measure Information:

Title

Normoglycemia on Therapy

Description

Time Frame

(1) 8 weeks and (2) 16 weeks

Secondary Outcome Measure Information:

Title

Description

Normal glucose tolerance is defined as a fasting plasma glucose <6.1 mmol/L and a 2-hour pc plasma glucose <7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs.

Time Frame

(1) 20 weeks and (2) 28 weeks

Title

Percentage of Participants With Normal Fasting Plasma Glucose

Description

Normal fasting plasma glucose is defined as <6.1 mmol/L.

Time Frame

52 weeks

Title

Change in Fasting Plasma Glucose From Baseline

Time Frame

Baseline and 52 weeks

Title

HbA1C

Time Frame

8, 20, 28 and 52 weeks

Title

Change in Weight From Baseline

Time Frame

Baseline, 8, 20, 28 and 52 weeks

Title

Number of Participants With Symptomatic Hypoglycemic Episodes

Time Frame

52 weeks

Title

Number of Participants With Severe Hypoglycemic Episodes

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men and women 30-80 years of age inclusive type 2 diabetes mellitus diagnosed by a physician within 3 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 ≤ 8.5% on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 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 therapy history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance 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 inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction 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 pulmonary disease with dependence on oxygen history of any disease requiring intermittent or 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 any history of excessive alcohol intake, acute or chronic known hypersensitivity to metformin, acarbose, or insulin glargine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hertzel Gerstein, MD

Organizational Affiliation

Population Health Research Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Natalia McInnes (nee Yakubovich), MD

Organizational Affiliation

Population Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University Medical Centre, Diabetes Care and Research Program

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

28324049

Citation

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.

Results Reference

result

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

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