| Trial ID: | L7024 |
| Source ID: | NCT02623998
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02623998/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: insulin glargine|DRUG: sitagliptin/metformin|BEHAVIORAL: lifestyle therapy
|
| Outcome Measures: |
Primary: Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group, Hyperglycemia relapse for primary outcome was defined as any one of: 1. Capillary glucose \>10 mmol/L on \>/=50% of readings over 1 week; 2. HbA1C \>/=6.5%; 3. use of diabetes drugs; 4. fasting plasma glucose \>/= 7.0 mmol/L; 5. 2-hour postprandial plasma glucose \>/=11.1 mmol/L on an oral glucose tolerance test., 64 weeks of follow-up|Number of Participants With Severe Hypoglycemic Episodes, 64 weeks of follow-up | Secondary: Number of Participants Achieving Drug-free Diabetes Remission, Diabetes remission is defined as absence of hyperglycemia relapse, 24 weeks after randomization|Number of Participants With Drug-free Normal Glucose Tolerance, Normal glucose tolerance is defined as a FPG\<6.1 mmol/L and a 2-hour plasma glucose \<7.8 mmol/L on a 75 g oral glucose tolerance test, 24 weeks after randomization|Percent Change in Weight, Baseline and 12 weeks after randomization|Change in Waist Circumference, Baseline and 12 weeks after randomization
|
| Sponsor/Collaborators: |
Sponsor: Population Health Research Institute | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-07-09
|
| Completion Date: |
2019-11-30
|
| Results First Posted: |
2022-03-14
|
| Last Update Posted: |
2022-03-25
|
| Locations: |
University of Calgary, Calgary, Alberta, T2T 5C7, Canada|Health Science Centre, Winnipeg, Manitoba, R3E 3P4, Canada|McMaster University, Hamilton, Ontario, Canada|St. Joseph's Hospital, London, Ontario, N6A 4V2, Canada|LMC, Markham, Ontario, Canada|Univeristy of Montreal, Montreal, Quebec, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02623998
|
