Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Metformin
* Drug: sulfonylurea (SU)
* Drug: Basal Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SU+metformin + Basal Insulin<br>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 | Drug: Metformin<br>* metformin is to be kept unchanged<br>Drug: sulfonylurea (SU)<br> <br> Drug: Basal Insulin<br> <br> |
| Experimental: Metformin/vildagliptin + Basal Insulin<br>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 | Drug: Vildagliptin<br>* 50 mg b.i.d<br>* Other names: Galvus;Drug: Metformin<br>* metformin is to be kept unchanged<br>Drug: Basal Insulin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events | Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7% | 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 | 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 | 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 | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, basal insulin, vildagliptin