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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
McMaster University Medical Centre, Diabetes Care and Research Program
Hamilton, Ontario, Canada
Normoglycemia on Therapy
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.
Time frame: (1) 8 weeks and (2) 16 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.
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
Percentage of Participants With Normal Fasting Plasma Glucose
Normal fasting plasma glucose is defined as \<6.1 mmol/L.
Time frame: 52 weeks
Change in Fasting Plasma Glucose From Baseline
Time frame: Baseline and 52 weeks
HbA1C
Time frame: 8, 20, 28 and 52 weeks
Change in Weight From Baseline
Time frame: Baseline, 8, 20, 28 and 52 weeks
Number of Participants With Symptomatic Hypoglycemic Episodes
Time frame: 52 weeks
Number of Participants With Severe Hypoglycemic Episodes
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diet and exercise
sc injection
oral administration
oral administration
diet and exercise
as informed by the current clinical practice guidelines
Time frame: 52 weeks