Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
ADDONIS
Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU
1 other identifier
interventional
42
1 country
19
Brief Summary
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2013
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 23, 2016
CompletedApril 21, 2016
March 1, 2016
1.7 years
June 4, 2013
February 22, 2016
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms
24 weeks
Secondary Outcomes (6)
Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events
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
24 weeks
- +1 more secondary outcomes
Study Arms (2)
SU+metformin + Basal Insulin
ACTIVE COMPARATORRandomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Metformin/vildagliptin + Basal Insulin
EXPERIMENTALRandomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
Interventions
metformin is to be kept unchanged
Eligibility Criteria
You may qualify if:
- T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
- with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
- with a glycemic target of HbA1c \<= 7%
- Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)
You may not qualify if:
- contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
- acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Disclosure Office
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 21, 2016
Results First Posted
March 23, 2016
Record last verified: 2016-03