Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

Tracking Information
First Submitted Date ICMJE	December 6, 2010
First Posted Date ICMJE	December 9, 2010
Last Update Posted Date	December 18, 2012
Study Start Date ICMJE	December 2010
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 8, 2010)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01257451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 8, 2010)	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 ]; To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo [ Time Frame: 24 weeks ]; To assess the responder rates of patients treated with vildagliptin as compared to placebo [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
Official Title ICMJE	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)
Brief Summary	This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes Mellitus
Intervention ICMJE	Drug: Vildagliptin vildagliptin 50mg bid; Drug: Placebo Placebo 50mg bid
Study Arms	Experimental: Vildagliptin Intervention: Drug: Vildagliptin; Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldánius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 14, 2012)	431
Original Estimated Enrollment ICMJE; (submitted: December 8, 2010)	280
Actual Study Completion Date	March 2012
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	70 Years and older (Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Bulgaria, Finland, Germany, Slovakia, Spain, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01257451
Other Study ID Numbers ICMJE	CLAF237A23150; 2010-022658-18
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Pharmaceuticals )
Study Sponsor ICMJE	Novartis Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	December 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP