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.
ConditionType 2 Diabetes Mellitus (T2DM)
InterventionDrug: Vildagliptin
Drug: Metformin
Drug: sulfonylurea (SU)
Drug: Basal Insulin
PhasePhase 3
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT01871558
First ReceivedJune 4, 2013
Last UpdatedApril 4, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateJune 4, 2013
Last Updated DateApril 4, 2014
Start DateJune 2013
Estimated Primary Completion DateOctober 2014
Current Primary Outcome MeasuresPercentage 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
  • Percentage of patients reaching their glycemic target without hypoglycemic events [Time Frame: 24 weeks] [Designated as safety issue: No]Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%
  • Change from baseline in HbA1c to week 24 in both treatment arms [Time Frame: Baseline, Week 24] [Designated as safety issue: No]
  • Change from baseline in body weight in both treatment arms [Time Frame: Baseline, Week 24] [Designated as safety issue: No]
  • Mean daily insulin dose at Week 24 [Time Frame: Week 24] [Designated as safety issue: No]
  • Percentage of patients with severe and confirmed hypoglycemic events [Time Frame: 24 weeks] [Designated as safety issue: Yes]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

Descriptive Information[ + expand ][ + ]

Brief TitleVildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Official TitleRandomized, 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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus (T2DM)
InterventionDrug: 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)
  • Active Comparator: SU+metformin + Basal Insulin
    Randomized 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
  • Experimental: Metformin/vildagliptin + Basal Insulin
    Randomized 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment170
Estimated Completion DateOctober 2014
Estimated Primary Completion DateOctober 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Novartis Pharmaceuticals
+41613241111
Location CountriesFrance

Administrative Information[ + expand ][ + ]

NCT Number NCT01871558
Other Study ID NumbersCLAF237AFR07
Has Data Monitoring CommitteeNo
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateApril 2014

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