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Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01224366
First received: October 18, 2010
Last updated: February 21, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Vildagliptin Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- HbA1c reduction [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 448 |
| Study Start Date: | September 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vildagliptin | Drug: Vildagliptin |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01224366
Show 66 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224366
Show 66 Study Locations
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
Publications:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01224366 History of Changes |
| Other Study ID Numbers: |
CLAF237A23135 |
| Study First Received: | October 18, 2010 |
| Last Updated: | February 21, 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 |
ClinicalTrials.gov processed this record on September 19, 2017