| Trial ID: | L3722 |
| Source ID: | NCT01755468
|
| Associated Drug: |
Intermittent Insulin Therapy
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| Title: |
Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Pilot Study)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Intermittent insulin therapy|DRUG: Continuous metformin
|
| Outcome Measures: |
Primary: Baseline-adjusted beta-cell function at 2 years, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)., ISSI-2 is an established measure of beta-cell function. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve to the area-under-the-glucose curve and (ii) insulin sensitivity measured by the Matsuda index., 2 years | Secondary: Baseline-adjusted glycemic control at 2-years., The secondary outcome of baseline-adjusted glycemic control at 2-years will be assessed by A1c (glycated hemoglobin), 2 years | Other: Achievement of target glycemic control, Achievement of target glycemic control will be assessed by the proportion of participants with A1c \<7.0%, 2 years|achievement of glucose tolerance in the non-diabetic range, The proportion of participants with glucose tolerance in the non-diabetic range will be determined on oral glucose tolerance test (OGTT) and defined based on current Canadian Diabetes Association classifications for glucose tolerance status on OGTT., 2 years|achievement of normal glucose tolerance, The proportion of participants with normal glucose tolerance will be determined on oral glucose tolerance test (OGTT) and defined based on current Canadian Diabetes Association classifications for glucose tolerance status on OGTT., 2 years|insulin sensitivity, Insulin sensitivity will be measured by Matsuda index, a clamp-validated measure of whole-body insulin sensitivity that can be obtained from the oral glucose tolerance test, 2 years
|
| Sponsor/Collaborators: |
Sponsor: Mount Sinai Hospital, Canada | Collaborators: Canadian Institutes of Health Research (CIHR)
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2017-10
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| Results First Posted: |
|
| Last Update Posted: |
2018-08-16
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| Locations: |
Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada
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| URL: |
https://clinicaltrials.gov/show/NCT01755468
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