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Clinical Trial Details

Trial ID: L3257
Source ID: NCT00978263
Associated Drug: Metformin-Based Oral Antidiabetic Drugs
Title: Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: metformin-based Oral Antidiabetic Drugs|DRUG: Glargine
Outcome Measures: Primary: Glycosylated Hemoglobin (HbA1c) at month 6, month 6|Change From Baseline in Glycosylated Hemoglobin at month 6, Baseline and month 6 | Secondary: Glycosylated Hemoglobin at month 12, month 12|Change From Baseline in Glycosylated Hemoglobin at month 12, Baseline and month 12|Number of Participants With Glycosylated Hemoglobin ≤ 7%, month 6|Number of Participants With Glycosylated Hemoglobin ≤ 7%, month 12|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%, month 6|Number of Participants With Glycosylated Hemoglobin ≤ 6.5%, month 12|Fasting Plasma Glucose at week 2, week 2|Fasting Plasma Glucose at week 4, week 4|Fasting Plasma Glucose at week 8, week 8|Fasting Plasma Glucose at week 12, week 12|Fasting Plasma Glucose at week 16, week 16|Fasting Plasma Glucose at week 20, week 20|Fasting Plasma Glucose at week 24, week 24|Fasting Plasma Glucose at week 32, week 32|Fasting Plasma Glucose at week 40, week 40|Fasting Plasma Glucose at week 48, week 48|Homeostasis model assessment (HOMA)-β at month 6, month 6|Insulinogenic index at month 6, month 6|HOMA-IR at month 6, month 6|Matsuda index at month 6, month 6|Basal disposition index at month 6, month 6|Early-phase disposition index at month 6, month 6|Homeostasis model assessment (HOMA)-β at month 12, month 12|Insulinogenic index at month 12, month 12|HOMA-IR at month 12, month 12|Matsuda index at month 12, month 12|Basal disposition index at month 12, month 12|Early-phase disposition index at month 12, month 12|Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score, month 6|DTSQs score at month 12, month 12|Audit of Diabetes Dependent Quality of Life (ADDQoL) score, month 6|ADDQoL score at month 12, month 12|Cost at month 6, month 6|Number of Participants with Hypoglycemia, up to 6 month|Number of hypoglycemia episodes, up to 6 month|Number of Participants with severe Hypoglycemia, up to 6 month|Number of severe hypoglycemia episodes, up to 6 month|Change From Baseline in Body Weight (month 6), Baseline and month 6|Change From Baseline in Body Weight (month 12), Baseline and month 12
Sponsor/Collaborators: Sponsor: Chongqing Medical University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 47
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-02
Completion Date: 2012-06
Results First Posted:
Last Update Posted: 2013-02-05
Locations: the First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China
URL: https://clinicaltrials.gov/show/NCT00978263