Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: Vildagliptin; Drug: Metformin; Drug: sulfonylurea (SU); Drug: Basal Insulin

• Registration Number: NCT01871558
• Lead Sponsor: Novartis Pharmaceuticals

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2016-02-22
• Results First Submitted QC: 2016-02-22
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Results First Posted: 2016-03-23
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SU+metformin + Basal Insulin	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
Metformin/vildagliptin + Basal Insulin	Vildagliptin	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
Metformin/vildagliptin + Basal Insulin	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
SU+metformin + Basal Insulin	sulfonylurea (SU)	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
SU+metformin + Basal Insulin	Metformin	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
Metformin/vildagliptin + Basal Insulin	Metformin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change From Baseline in Body Weight in Both Treatment Arms	Baseline, Week 24
Change From Baseline in HbA1c to Week 24 in Both Treatment Arms	Baseline, Week 24
Mean Daily Insulin Dose at Week 24	Week 24
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)	week 24	HbA1c \<= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain
Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events	24 weeks	Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%
Percentage of Patients With Severe and Confirmed Hypoglycemic Events	24 weeks	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Valenciennes, France