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Clinical Trial Details

Trial ID: L4299
Source ID: NCT01871558
Associated Drug: Vildagliptin
Title: Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Acronym: ADDONIS
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01871558/results
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Vildagliptin|DRUG: Metformin|DRUG: sulfonylurea (SU)|DRUG: Basal Insulin
Outcome Measures: Primary: Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms, 24 weeks | Secondary: Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events, Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%, 24 weeks|Change From Baseline in HbA1c to Week 24 in Both Treatment Arms, Baseline, Week 24|Change From Baseline in Body Weight in Both Treatment Arms, Baseline, Week 24|Mean Daily Insulin Dose at Week 24, Week 24|Percentage of Patients With Severe and Confirmed Hypoglycemic Events, Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) \< 70 mg/dL, 24 weeks|Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline), HbA1c \<= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain, week 24
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-06
Completion Date: 2015-02
Results First Posted: 2016-03-23
Last Update Posted: 2016-04-21
Locations: Novartis Investigative Site, Antibes, 06600, France|Novartis Investigative Site, Auxerre, 89000, France|Novartis Investigative Site, Bar le Duc, 55012, France|Novartis Investigative Site, Bondy, 93143, France|Novartis Investigative Site, Brest, 29200, France|Novartis Investigative Site, Caen, 14000, France|Novartis Investigative Site, Corbeil Essonnes, 91100, France|Novartis Investigative Site, Fleury sur Orne, 14123, France|Novartis Investigative Site, Maisons Laffitte, 78600, France|Novartis Investigative Site, Menton, 06500, France|Novartis Investigative Site, Montpellier, 34090, France|Novartis Investigative Site, Paris, 75010, France|Novartis Investigative Site, Rennes, 35203, France|Novartis Investigative Site, Saint Nazaire, 44600, France|Novartis Investigative Site, Sanary Sur Mer, 83110, France|Novartis Investigative Site, Strsbourg, 67000, France|Novartis Investigative Site, Toulouse, 31300, France|Novartis Investigative Site, Valence, 26000, France|Novartis Investigative Site, Valenciennes, 59300, France
URL: https://clinicaltrials.gov/show/NCT01871558

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D432 Vildagliptin small molecule DB04876 Details
D089 Metformin small molecule DB00331 Details