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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: insulin glargine; Other: Standard glycemic care; Drug: metformin; Drug: acarbose; Behavioral: lifestyle therapy

• Registration Number: NCT01181674
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Study Start: 2011-01
• Primary Completion: 2015-02
• Study Completion: 2015-09
• Results First Submitted: 2020-04-06
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-10
• Last Update Submitted: 2020-05-10
• Results First Posted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (short)	insulin glargine	-
Group 1 (short)	acarbose	-
Group 2 (long)	lifestyle therapy	-
Standard care	Standard glycemic care	-
Group 2 (long)	insulin glargine	-
Group 2 (long)	metformin	-
Group 1 (short)	metformin	-
Group 1 (short)	lifestyle therapy	-
Group 2 (long)	acarbose	-

Primary Outcome Measures

Name	Time	Method
Normoglycemia on Therapy	(1) 8 weeks and (2) 16 weeks	1. Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group.; 2. 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

Name	Time	Method
Number of Participants With Symptomatic Hypoglycemic Episodes	52 weeks
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.	(1) 20 weeks and (2) 28 weeks	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	52 weeks	Normal fasting plasma glucose is defined as \<6.1 mmol/L.
Number of Participants With Severe Hypoglycemic Episodes	52 weeks
Change in Fasting Plasma Glucose From Baseline	Baseline and 52 weeks
HbA1C	8, 20, 28 and 52 weeks
Change in Weight From Baseline	Baseline, 8, 20, 28 and 52 weeks

Trial Locations

Locations (1)

McMaster University Medical Centre, Diabetes Care and Research Program; 🇨🇦 Hamilton, Ontario, Canada