Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01224366 |
Recruitment Status
:
Completed
First Posted
: October 20, 2010
Last Update Posted
: February 23, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Vildagliptin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 448 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus. |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Vildagliptin | Drug: Vildagliptin |
Placebo Comparator: Placebo | Drug: Placebo |
- HbA1c reduction [ Time Frame: 24 weeks ]
- HbA1c reduction in subpopulation treated with insulin and with metformin [ Time Frame: 24 weeks ]
- HbA1c reduction in subpopulation treated with insulin and without metformin [ Time Frame: 24 weeks ]
- Reduction in FPG (overall and subpopulations) [ Time Frame: 24 weeks ]
- Responder rates (overall and subpopulations) [ Time Frame: 24 weeks ]
- Incidence of hypoglycemia and severe hypoglycemia (overall and subpopulations) [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224366

Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Publications of Results:
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01224366 History of Changes |
Other Study ID Numbers: |
CLAF237A23135 |
First Posted: | October 20, 2010 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | February 2017 |
Keywords provided by Novartis:
Add-on to insulin |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |