Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Novartis Pharmaceuticals42 enrolled

Overview

To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

VildagliptinDRUG

50 mg b.i.d

MetforminDRUG

metformin is to be kept unchanged

sulfonylurea (SU)DRUG

Basal InsulinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Novartis Investigative Site

Antibes, France

Novartis Investigative Site

Auxerre, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events

Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%

Time frame: 24 weeks

Change From Baseline in HbA1c to Week 24 in Both Treatment Arms

Time frame: Baseline, Week 24

Change From Baseline in Body Weight in Both Treatment Arms

Time frame: Baseline, Week 24

Mean Daily Insulin Dose at Week 24

Time frame: 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

Time frame: 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

Time frame: week 24

Data from ClinicalTrials.gov

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