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Clinical Trial Details

Trial ID: L5259
Source ID: NCT01195090
Associated Drug: Sitagliptin
Title: Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea
Acronym: JAS
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01195090/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Sitagliptin|DRUG: pioglitazone
Outcome Measures: Primary: Mean Change in Glycosylated Hemoglobin (A1C), A1C change from baseline to 24 weeks, 24 weeks|Baseline A1C, baseline A1C, Baseline|The Percentages of Patient Achieving an A1C <7%, The percentages of patient achieving an A1C \<7% at endpoint, 24 weeks | Secondary: Changes in Fasting Plasma Glucose, fasting serum sugar change from baseline to 24 weeks, 24 weeks|Changes in High Sensitive C-reactive Protein, fasting high sensitive serum C-reactive protein change from baseline to 24 weeks, 24 weeks|Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR), HOMA-IR change from baseline to 24 weeks, 24 weeks|Body Weight Change, body weight change from baseline to 24 weeks, 24 weeks|Percentages of Patients With Total Adverse Events (AE), percentages of total adverse events, 24 weeks|Change in Fasting Total-cholesterol, Total-cholesterol change from baseline to 24 weeks, 24 weeks|Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C), LDL-C change from baseline to 24 weeks, 24 weeks|Change in Fasting Triglycerides(TG), TG change from baseline to 24 weeks, 24 weeks|Change in Fasting High-density Lipoprotein Cholesterol(HDL-C), HDL-C change from baseline to 24 weeks, 24 weeks|Change in Fasting Plasma Alanine-aminotransferase (ALT), ALT change from baseline to 24 weeks, 24 weeks|Percentages of Patients With Mild to Moderate Hypoglycemia, Incidence of mild to moderate hypoglycemia after treatment, 24 weeks|Percentages of Patients With Edema, proportion of edema after treatment, 24 weeks|Percentages of Patients With Gastrointestinal Adverse Events, Proportion of Gastrointestinal adverse events after treatment, 24 weeks|Percentages of Patients With Nasopharyngitis, Proportion of Nasopharyngitis after treatment, 24 weeks|Percentages of Patients With Severe Hypoglycemia, Proportion of severe hypoglycemia after treatment, 24 weeks|Baseline Fasting Plasma Glucose, Baseline fasting plasma glucose, baseline|Baseline High Sensitive C-reactive Protein, Baseline high sensitive C-reactive Protein, baseline|Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR), Baseline HOMA-IR, Baseline HOMA-IR|Baseline Alanine-aminotransferase (ALT), Baseline alanine-aminotransferase, Baseline|Baseline Body Weight, Baseline body weight, Baseline|Baseline Total Cholesterol, Baseline Total cholesterol, Baseline|Baseline Triglyceride (TG), Baseline TG, Baseline|Baseline Low-density Lipoprotein Cholesterol (LDL-C), Baseline LDL-C, Baseline|Baseline High-density Lipoprotein Cholesterol (HDL-C), Baseline HDL-C, Baseline
Sponsor/Collaborators: Sponsor: Sung-Chen Liu | Collaborators: Mackay Memorial Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-10
Completion Date: 2012-04
Results First Posted: 2012-10-10
Last Update Posted: 2012-10-10
Locations: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, 10449, Taiwan
URL: https://clinicaltrials.gov/show/NCT01195090