Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01257451
First received: December 6, 2010
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
| 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- To assess the responder rates of patients treated with vildagliptin as compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 431 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vildagliptin |
Drug: Vildagliptin
vildagliptin 50mg bid
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo 50mg bid
|
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age: ≥ 70 years inclusive at Visit 1.
- patients with a confirmed diagnosis of T2DM
- HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
- body mass index (BMI) in the range of 19-45kg/m2
Exclusion Criteria:
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- previous or current participation in any vildagliptin clinical study.
- history of hypersensitivity to DPP-4 inhibitors.
- concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257451
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Hide Study LocationsLocations
| Belgium | |
| Novartis Investigative Site | |
| Buizingen, Belgium, 1501 | |
| Novartis Investigative Site | |
| De Pinte, Belgium, 9840 | |
| Novartis Investigative Site | |
| Genk, Belgium, 3600 | |
| Novartis Investigative Site | |
| Mouscron, Belgium, 7700 | |
| Novartis Investigative Site | |
| Nazareth, Belgium, 9810 | |
| Novartis Investigative Site | |
| Oostham, Belgium, 3945 | |
| Novartis Investigative Site | |
| Wichelen, Belgium, 9260 | |
| Bulgaria | |
| Novartis Investigative Site | |
| Blagoevgrad, Bulgaria, 2700 | |
| Novartis Investigative Site | |
| Dimitrovgrad, Bulgaria, 6400 | |
| Novartis Investigative Site | |
| Pleven, Bulgaria, 5800 | |
| Novartis Investigative Site | |
| Plovdiv, Bulgaria, 4001 | |
| Novartis Investigative Site | |
| Sofia, Bulgaria, 1431 | |
| Novartis Investigative Site | |
| Varna, Bulgaria, 9002 | |
| Finland | |
| Novartis Investigative Site | |
| Lahti, Suomi, Finland, 15110 | |
| Novartis Investigative Site | |
| Helsinki, Finland, 00180 | |
| Novartis Investigative Site | |
| Oulu, Finland, FIN-90100 | |
| Germany | |
| Novartis Investigative Site | |
| Bamberg, Germany, 96050 | |
| Novartis Investigative Site | |
| Beckum, Germany, 59269 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10115 | |
| Novartis Investigative Site | |
| Falkensee, Germany, 14612 | |
| Novartis Investigative Site | |
| Lichtenfels, Germany, 96215 | |
| Novartis Investigative Site | |
| Lutherstadt Eisleben, Germany, 06295 | |
| Novartis Investigative Site | |
| Magdeburg, Germany, 39112 | |
| Novartis Investigative Site | |
| Mammendorf, Germany, 82291 | |
| Novartis Investigative Site | |
| Münster, Germany, 48143 | |
| Novartis Investigative Site | |
| Potsdam, Germany, 14469 | |
| Novartis Investigative Site | |
| Sulzbach-Rosenberg, Germany, 92237 | |
| Novartis Investigative Site | |
| Völlkingen, Germany, 66333 | |
| Novartis Investigative Site | |
| Wetter, Germany, 58300 | |
| Slovakia | |
| Novartis Investigative Site | |
| Bratislava, Slovak Republic, Slovakia, 811 02 | |
| Novartis Investigative Site | |
| Lubochna, Slovak Republic, Slovakia, 03491 | |
| Novartis Investigative Site | |
| Kosice, Slovakia, 040 22 | |
| Novartis Investigative Site | |
| Levice, Slovakia, 934 01 | |
| Novartis Investigative Site | |
| Nové Zámky, Slovakia, 940 01 | |
| Novartis Investigative Site | |
| Pie¿¿any, Slovakia, 92101 | |
| Novartis Investigative Site | |
| Ruzomberok, Slovakia, 034 01 | |
| Spain | |
| Novartis Investigative Site | |
| Sanlúcar de Barrameda, Andalucía, Spain, 11540 | |
| Novartis Investigative Site | |
| Centelles, Barcelona, Spain, 08540 | |
| Novartis Investigative Site | |
| Alzira, Comunidad Valenciana, Spain, 46600 | |
| Novartis Investigative Site | |
| Alicante, Spain, 03114 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Truro, Cornwall, United Kingdom, TR1 3LJ | |
| Novartis Investigative Site | |
| Birmingham, United Kingdom, B9 5SS | |
| Novartis Investigative Site | |
| Exeter, United Kingdom, EX2 5DW | |
| Novartis Investigative Site | |
| Stevenage, United Kingdom, SG1 4AB | |
| Novartis Investigative Site | |
| Wiltshire, United Kingdom, SN15 2SB | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Study Director: | Novartis Pharmaceuticals Corporation | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01257451 History of Changes |
| Other Study ID Numbers: | CLAF237A23150, 2010-022658-18 |
| Study First Received: | December 6, 2010 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Ministry of Education and Research Slovakia: State Institute for Drug Control Spain: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013