| Trial ID: | L3101 |
| Source ID: | NCT01181674
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01181674/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: insulin glargine|DRUG: metformin|DRUG: acarbose|BEHAVIORAL: lifestyle therapy|DRUG: insulin glargine|DRUG: metformin|DRUG: acarbose|BEHAVIORAL: lifestyle therapy|OTHER: Standard glycemic care
|
| Outcome Measures: |
Primary: 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., (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|Percentage of Participants With Normal Fasting Plasma Glucose, Normal fasting plasma glucose is defined as \<6.1 mmol/L., 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|Number of Participants With Symptomatic Hypoglycemic Episodes, 52 weeks|Number of Participants With Severe Hypoglycemic Episodes, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Population Health Research Institute | Collaborators: Hamilton Health Sciences Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
83
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-01
|
| Completion Date: |
2015-09
|
| Results First Posted: |
2020-05-21
|
| Last Update Posted: |
2020-05-21
|
| Locations: |
McMaster University Medical Centre, Diabetes Care and Research Program, Hamilton, Ontario, L8N 3Z5, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT01181674
|
