CClinicalTrials.gg
CompletedNCT01224366Updated Feb 23, 2017

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

A Phase 3 interventional study of Vildagliptin and Placebo in Type 2 Diabetes Mellitus, sponsored by Novartis. Completed at 66 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
448
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Add-on to insulin
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 448 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
448 participants (actual)

Study arms

  • Experimental
    Vildagliptin

    Drug: Vildagliptin

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugVildagliptin
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. HbA1c reduction

    Time frame: 24 weeks

Secondary outcomes

  1. HbA1c reduction in subpopulation treated with insulin and with metformin

    Time frame: 24 weeks

  2. HbA1c reduction in subpopulation treated with insulin and without metformin

    Time frame: 24 weeks

  3. Reduction in FPG (overall and subpopulations)

    Time frame: 24 weeks

  4. Responder rates (overall and subpopulations)

    Time frame: 24 weeks

  5. Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations)

    Time frame: 24 weeks

07

Study locations

66 sites
  • Novartis Investigative Site
    Box Hill, Australia
  • Novartis Investigative Site
    Heidelberg Heights, Australia
  • Novartis Investigative Site
    Parkville, Australia
  • Novartis Investigative Site #1
    Wollongong, Australia
  • Novartis Investigative Site #2
    Wollongong, Australia
  • Novartis Investigative Site
    Bonheiden, Belgium
  • Novartis Investigative Site
    Edegem, Belgium
  • Novartis Investigative Site
    Genk, Belgium
  • Novartis Investigative Site
    La Louviere, Belgium
  • Novartis Investigative Site
    Ronse, Belgium
  • Novartis Investigative Site #1
    Ostrava, Czech Republic
  • Novartis Investigative Site #2
    Ostrava, Czech Republic
  • Novartis Investigative Site #3
    Ostrava, Czech Republic
  • Novartis Investigative Site
    Asslar, Germany
  • Novartis Investigative Site
    Bensheim, Germany
  • Novartis Investigative Site
    Berlin, Germany
  • Novartis Investigative Site
    Einbeck, Germany
  • Novartis Investigative Site #1
    Hamburg, Germany
  • Novartis Investigative Site #2
    Hamburg, Germany
  • Novartis Investigative Site #3
    Hamburg, Germany
  • Novartis Investigative Site #4
    Hamburg, Germany
  • Novartis Investigative Site
    Hannover, Germany
  • Novartis Investigative Site #1
    Kassel, Germany
  • Novartis Investigative Site #2
    Kassel, Germany
  • Novartis Investigative Site
    Munchen, Germany
  • Novartis Investigative Site
    Neubukow, Germany
  • Novartis Investigative Site
    Saarlouis, Germany
  • Novartis Investigative Site
    Tubingen, Germany
  • Novartis Investigative Site #1
    Guatemala City, Guatemala
  • Novartis Investigative Site #2
    Guatemala City, Guatemala
  • Novartis Investigative Site #3
    Guatemala City, Guatemala
  • Novartis Investigative Site #4
    Guatemala City, Guatemala
  • Novartis Investigative Site #5
    Guatemala City, Guatemala
  • Novartis Investigative Site #1
    Hong Kong, Hong Kong
  • Novartis Investigative Site #2
    Hong Kong, Hong Kong
  • Novartis Investigative Site #1
    Budapest, Hungary
  • Novartis Investigative Site #2
    Budapest, Hungary
  • Novartis Investigative Site
    Dunaujvaros, Hungary
  • Novartis Investigative Site
    Nyiregyhaza, Hungary
  • Novartis Investigative Site
    Szeged, Hungary
  • Novartis Investigative Site
    Indore, India
  • Novartis Investigative Site
    Jaipur, India
  • Novartis Investigative Site
    Karnal, India
  • Novartis Investigative Site #2
    Mumbai, India
  • Novartis Investigative Site #1
    Mumbia, India
  • Novartis Investigative Site #1
    Nagpur, India
  • Novartis Investigative Site #2
    Nagpur, India
  • Novartis Investigative Site
    Nasik, India
  • Novartis Investigative Site #1
    Trivandrum, India
  • Novartis Investigative Site #2
    Trivandrum, India
  • Novartis Investigative Site
    Alba-Iulia, Romania
  • Novartis Investigative Site
    Bucharest, Romania
  • Novartis Investigative Site #1
    Oradea, Romania
  • Novartis Investigative Site #2
    Oradea, Romania
  • Novartis Investigative Site
    Targu-Mures, Romania
  • Novartis Investigative Site
    Banska Bystrica, Slovakia
  • Novartis Investigative Site #1
    Bratislava, Slovakia
  • Novartis Investigative Site #2
    Bratislava, Slovakia
  • Novartis Investigative Site #3
    Bratislava, Slovakia
  • Novartis Investigative Site #1
    Kosice, Slovakia
  • Novartis Investigative Site #2
    Kosice, Slovakia
  • Novartis Investigative Site
    Presov, Slovakia
  • Novartis Investigative Site
    Sturovo, Slovakia
  • Novartis Investigative Site
    Carmarthen, United Kingdom
  • Novartis Investigative Site #1
    Glasgow, United Kingdom
  • Novartis Investigative Site #2
    Glasgow, United Kingdom
08

References and documents

Publications

  • Kozlovski P, Foley J, Shao Q, Lukashevich V, Kothny W. Vildagliptin-insulin combination improves glycemic control in Asians with type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):151-6. doi: 10.4239/wjd.v4.i4.151. PubMed 23961326 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01224366
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Oct 20, 2010
Start date
Sep 2010
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Feb 23, 2017

Study contacts

Novartis Pharmaceuticals
study chair · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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