Clinical trial NCT01871558: Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: type 2 diabetes
basal insulin
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events
timeFrame: 24 weeks
measure: Change From Baseline in HbA1c to Week 24 in Both Treatment Arms
timeFrame: Baseline, Week 24
measure: Change From Baseline in Body Weight in Both Treatment Arms
timeFrame: Baseline, Week 24
measure: Mean Daily Insulin Dose at Week 24
timeFrame: Week 24
measure: Percentage of Patients With Severe and Confirmed Hypoglycemic Events
timeFrame: 24 weeks
measure: 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)
timeFrame: week 24
Other outcomes:
Locations:
city: Antibes
country: France
facility: Novartis Investigative Site
city: Auxerre
country: France
facility: Novartis Investigative Site
city: Bar le Duc
country: France
facility: Novartis Investigative Site
city: Bondy
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Corbeil Essonnes
country: France
facility: Novartis Investigative Site
city: Fleury sur Orne
country: France
facility: Novartis Investigative Site
city: Maisons Laffitte
country: France
facility: Novartis Investigative Site
city: Menton
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Rennes
country: France
facility: Novartis Investigative Site
city: Saint Nazaire
country: France
facility: Novartis Investigative Site
city: Sanary Sur Mer
country: France
facility: Novartis Investigative Site
city: Strsbourg
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Valence
country: France
facility: Novartis Investigative Site
city: Valenciennes
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: