Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Overview[ - collapse ][ - ]
Purpose | To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks. |
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Condition | Type 2 Diabetes Mellitus (T2DM) |
Intervention | Drug: Vildagliptin Drug: Metformin Drug: sulfonylurea (SU) Drug: Basal Insulin |
Phase | Phase 3 |
Sponsor | Novartis Pharmaceuticals |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT01871558 |
First Received | June 4, 2013 |
Last Updated | April 4, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | June 4, 2013 |
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Last Updated Date | April 4, 2014 |
Start Date | June 2013 |
Estimated Primary Completion Date | October 2014 |
Current Primary Outcome Measures | Percentage of patients who reported at least one symptomatic hypoglycemic event during the 24 week randomized period in both treatment arms [Time Frame: 24 weeks] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin |
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Official Title | 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 |
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. |
Detailed Description | This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus (T2DM) |
Intervention | Drug: Vildagliptin 50 mg b.i.d Other Names: GalvusDrug: Metformin metformin is to be kept unchanged Drug: sulfonylurea (SU) Drug: Basal Insulin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 170 |
Estimated Completion Date | October 2014 |
Estimated Primary Completion Date | October 2014 |
Eligibility Criteria | Inclusion Criteria: - 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% - with HbA1c at inclusion >7% and <=9% - Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG) Exclusion Criteria: - 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 Other protocol defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Novartis Pharmaceuticals +41613241111 |
Location Countries | France |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01871558 |
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Other Study ID Numbers | CLAF237AFR07 |
Has Data Monitoring Committee | No |
Information Provided By | Novartis |
Study Sponsor | Novartis Pharmaceuticals |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Novartis Investigative Site | Angouleme, France, 16000 Not yet recruiting |
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Novartis Investigative Site | Annonay, France, 07100 Not yet recruiting |
Novartis Investigative Site | Antibes, France, 06600 Not yet recruiting |
Novartis Investigative Site | Auxerre, France, 89000 Recruiting |
Novartis Investigative Site | Avignon, France, 84000 Not yet recruiting |
Novartis Investigative Site | Banyuls sur Mer, France, 66650 Not yet recruiting |
Novartis Investigative Site | Beausoleil, France, 06240 Not yet recruiting |
Novartis Investigative Site | Benfeld, France, 67230 Not yet recruiting |
Novartis Investigative Site | Brest, France, 29200 Recruiting |
Novartis Investigative Site | Brest cedex, France, 29240 Not yet recruiting |
Novartis Investigative Site | Caen, France, 14000 Not yet recruiting |
Novartis Investigative Site | Chartres, France, 28000 Not yet recruiting |
Novartis Investigative Site | Derval, France, 44590 Not yet recruiting |
Novartis Investigative Site | Fleury sur Orne, France, 14123 Not yet recruiting |
Novartis Investigative Site | Le Chesnay, France Not yet recruiting |
Novartis Investigative Site | Menton, France, 06500 Not yet recruiting |
Novartis Investigative Site | Montpellier, France, 34090 Not yet recruiting |
Novartis Investigative Site | Montpellier, France, 34000 Not yet recruiting |
Novartis Investigative Site | Mougins, France, 06250 Not yet recruiting |
Novartis Investigative Site | Pringy cedex, France, 74374 Not yet recruiting |
Novartis Investigative Site | Saint Nazaira, France, 44600 Not yet recruiting |
Novartis Investigative Site | Sanary Sur Mer, France, 83110 Not yet recruiting |
Novartis Investigative Site | Strsbourg, France, 67000 Recruiting |
Novartis Investigative Site | Thionville Cedex, France, 57100 Not yet recruiting |
Novartis Investigative Site | Toul, France, 54200 Not yet recruiting |
Novartis Investigative Site | Toulouse, France, 31300 Not yet recruiting |
Novartis Investigative Site | Tours, France, 37000 Not yet recruiting |
Novartis Investigative Site | Witry les Reims, France, 51 420 Not yet recruiting |