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Clinical Trial Details

Trial ID: L5441
Source ID: NCT05290506
Associated Drug: Dipeptidyl-Peptidase Iv Inhibitors
Title: Linagliptin Response to OGTT in Prediabetes and Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: PreDiabetes|Type 2 Diabetes
Interventions: DRUG: Dipeptidyl-Peptidase IV Inhibitors
Outcome Measures: Primary: change from baseline in glucose after 12-week treatment, OGTT is performed at week 0 (baseline) and 12 (complete treatment). plasma glucose levels are taken at time 0,30,60,90,120 minutes during OGTT., baseline to 12 weeks|change from baseline in HbA1c after 12-week treatment, plasma level of fasting HbA1c is taken at week 0 and 12 of study before OGTT, baseline to 12 weeks|change from baseline in insulin sensitivity/resistance index after 12-week treatment, OGTT is performed at week 0 (baseline) and 12. Plasma levels of glucose and insulin are taken at time 0,30,60,90,120 min during the OGTT. HOMA-IR, HOMA-IS are used to measure insulin resistance and insulin sensitivity at week 0 and week 12, baseline to 12 weeks | Secondary: change from baseline in beta-cell function after 12-week treatment, OGTT is performed at week 0 (baseline) and 12 (treatment complete). HOMS-beta, insulinogenic index, oral disposition index are used to measure beta-cell funciton at week 0 and 12, baseline to 12 weeks
Sponsor/Collaborators: Sponsor: National University of Malaysia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-08-01
Completion Date: 2021-03-01
Results First Posted:
Last Update Posted: 2022-03-22
Locations: Hospital Sultan Ismail, Johor Bahru, Johor, 81100, Malaysia
URL: https://clinicaltrials.gov/show/NCT05290506