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Clinical Trial Details

Trial ID: L7309
Source ID: NCT02027753
Associated Drug: Insulin Glargine
Title: Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
Acronym: TED
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: INSULIN GLARGINE|DRUG: Metformin|DRUG: DPP-4 inhibitor|DRUG: Sulphonylurea
Outcome Measures: Primary: Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy, week 24 (6 months) | Secondary: Percentage of patients with HbA1c ≤7%, week 12 (3 months)|Change from baseline in HbA1c, week 12 (3 months), week 24 (6 months)|Percentage of patients with HbA1c ≤6.5%, week 12 (3 months), week 24 (6 months)|Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose, week 12 (3 months), week 24 (6 months)|Total daily insulin dose, week 24 (6 months)|Fasting blood glucose (FBG) values, During 3 consecutive days before baseline, week 12, Week 24|7-point Self Monitoring of Blood Glucose, During 2 days within 7 days before baseline, week 12, week 24|Weight change from baseline, week 24 (6 months)|Number of Patients with Hypoglycemic Events, up to 6 months|Number of Patients with Adverse Events, up to 6 months
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 109
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-12
Completion Date: 2015-04
Results First Posted:
Last Update Posted: 2015-08-27
Locations: Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02027753