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Clinical Trial Details

Trial ID: L1946
Source ID: NCT01270191
Associated Drug: Exenatide
Title: The Effects of Short-Term Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Exenatide|DRUG: Humulin-N
Outcome Measures: Primary: the time of glycemic remission and remission rate, The primary outcomes are the time of glycemic remission and remission rate at one year after short-term therapy., at one year|The time of monotherapy failure and monotherapy failure rate, The primary outcomes at 5 years are long-term glycemic control. After 5 months of intensive therapy, these patients were off medication and follow up in our clinics. When diabetes relapsed, they will be treated with metformin monotherapy. The monotherapy failure is defined as A1C \>7.0% with metformin 1500 mg per day., 5 years | Secondary: Beta-cell function and insulin sensitivity calculated from OGTT., The Beta-cell function and insulin sensitivity calculated from OGTT., at 6 months|Comparison of A1C change, the proportion of subjects who reached the treatment target, The secondary outcomes are the comparison of A1C change, the proportion of subjects who reached the treatment target (A1C \<7.0% or \<6.5%) at 6 months and 12 months., 6-12 months|Comparison of A1C change, the proportion of subjects who reached the treatment target, These subjects will be followed up for 5 years to evaluate their long-term glycemic control. The secondary outcomes are the comparison of A1C change, the proportion of subjects who reached the treatment target (A1C \<7.0% or \<6.5%) at 5 years., 5 years
Sponsor/Collaborators: Sponsor: Taipei Veterans General Hospital, Taiwan
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-11
Completion Date: 2015-12
Results First Posted:
Last Update Posted: 2013-06-27
Locations: Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT01270191