Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

— ADDONIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871558
• Other study ID #: CLAF237AFR07
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2013
• Last updated: January 5, 2016
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - French Health Products Safety Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• Vildagliptin
50 mg b.i.d
• Metformin
metformin is to be kept unchanged
• sulfonylurea (SU)

• Basal Insulin

Locations

Country	Name	City	State
France	Novartis Investigative Site	Antibes
France	Novartis Investigative Site	Auxerre
France	Novartis Investigative Site	Bar le Duc
France	Novartis Investigative Site	Bondy
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Corbeil Essonnes
France	Novartis Investigative Site	Fleury sur Orne
France	Novartis Investigative Site	Maisons Laffitte
France	Novartis Investigative Site	Menton
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Rennes
France	Novartis Investigative Site	Saint Nazaire
France	Novartis Investigative Site	Sanary Sur Mer
France	Novartis Investigative Site	Strsbourg
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Valence
France	Novartis Investigative Site	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who reported at least one symptomatic hypoglycemic event during the 24 week randomized period in both treatment arms		24 weeks	Yes
Secondary	Percentage of patients reaching their glycemic target without hypoglycemic events	Glycemic target is defined as Glycated hemoglobin(HbA1c) = 7%	24 weeks	No
Secondary	Change from baseline in HbA1c to week 24 in both treatment arms		Baseline, Week 24	No
Secondary	Change from baseline in body weight in both treatment arms		Baseline, Week 24	No
Secondary	Mean daily insulin dose at Week 24		Week 24	No
Secondary	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	Yes