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Clinical Trial Details

Trial ID: L5131
Source ID: NCT03577184
Associated Drug: Metformin/Vildagliptin
Title: Evaluating the Glycemic Control wIth Vildagliptin and Metformin Combination Therapy.
Acronym: GRIP
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin/Vildagliptin
Outcome Measures: Primary: Change from baseline in Random blood sugar (RBS) and fasting blood sugar (FBS) levels at week 12 in participants receiving Vildagliptin combination with Metformin, To determine the efficacy of vildagliptin/metformin changes from baseline in random blood sugar (RBS) and fasting blood sugar (FBS) levels after 12 weeks of therapy. \[Designated as safety issue: No \], Week 12 | Secondary: Changes from baseline in HbA1c Levels at Week 12 in participants receiving Vildagliptin combination with Metformin, To determine the efficacy of vildagliptin/metformin changes from baseline in HbA1c levels after 12 weeks of therapy. \[ Designated as safety issue: No \], Week 12|Number of participants experiencing hypoglycemic episodes in the 12 weeks receiving Vildagliptin combination with Metformin., To evaluate the number of participants experiencing hypoglycemic episodes in the 12 weeks \[ Designated as safety issue: Yes \], Week 12|Number of participants who experienced an Adverse Event, To evaluate the number of participants who experienced an adverse event after 12 weeks of therapy. \[ Designated as safety issue: Yes \], 12 weeks
Sponsor/Collaborators: Sponsor: Clinision
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 0
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-07
Completion Date: 2019-03
Results First Posted:
Last Update Posted: 2019-10-03
Locations:
URL: https://clinicaltrials.gov/show/NCT03577184