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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181674
• Other study ID #: REMIT Pilot
• Secondary ID: Control # 139433
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: September 2015

Study information

• Verified date: May 2020
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• insulin glargine
sc injection
• metformin
oral administration
• acarbose
oral administration

Behavioral:
• lifestyle therapy
diet and exercise

Drug:
• insulin glargine
sc injection
• metformin
oral administration
• acarbose
oral administration

Behavioral:
• lifestyle therapy
diet and exercise

Other:
• Standard glycemic care
as informed by the current clinical practice guidelines

Locations

Country	Name	City	State
Canada	McMaster University Medical Centre, Diabetes Care and Research Program	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	(1) 8 weeks and (2) 16 weeks
Secondary	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.	(1) 20 weeks and (2) 28 weeks
Secondary	Percentage of Participants With Normal Fasting Plasma Glucose	Normal fasting plasma glucose is defined as <6.1 mmol/L.	52 weeks
Secondary	Change in Fasting Plasma Glucose From Baseline		Baseline and 52 weeks
Secondary	HbA1C		8, 20, 28 and 52 weeks
Secondary	Change in Weight From Baseline		Baseline, 8, 20, 28 and 52 weeks
Secondary	Number of Participants With Symptomatic Hypoglycemic Episodes		52 weeks
Secondary	Number of Participants With Severe Hypoglycemic Episodes		52 weeks