Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Vildagliptin; Drug: Placebo

• Registration Number: NCT01224366
• Lead Sponsor: Novartis

Brief Summary

To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

• Confirmed diagnosis of T2DM
• On a stable dose of insulin as defined by the protocol
• On a stable does of metformin (if applicable) as defined by the protocol
• Age 18 to 80 years
• HbA1c of 7.5 to 11.0%
• Body Mass Index (BMI) 22 to 40 kg/m2

Exclusion Criteria

• Type 1 diabetes
• Short-acting or rapid-acting insulin
• Pregnancy or lactation
• Evidence of serious diabetic complications
• Evidence of serious cardiovascular complications
• Laboratory value abnormalities as defined by the protocol
• Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vildagliptin	Vildagliptin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
HbA1c reduction	24 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)	24 weeks
Responder rates (overall and subpopulations)	24 weeks
HbA1c reduction in subpopulation treated with insulin and with metformin	24 weeks
HbA1c reduction in subpopulation treated with insulin and without metformin	24 weeks
Reduction in FPG (overall and subpopulations)	24 weeks

Trial Locations

Locations (6)

Novartis Investigative Site; 🇬🇧 Carmarthen, United Kingdom

Novartis Investigative Site #3; 🇸🇰 Bratislava, Slovakia

Novartis Investigative Site #2; 🇬🇧 Glasgow, United Kingdom

Novartis Investigative Site #1; 🇬🇧 Glasgow, United Kingdom

Novartis Investigative Site #5; 🇬🇹 Guatemala City, Guatemala

Novartis Investigative Site #4; 🇬🇹 Guatemala City, Guatemala