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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: 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.
For general information, see Learn About Clinical Studies.
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 June 23, 2017