Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 6, 2010

Last Updated Date

December 14, 2012

Start Date ^ICMJE

December 2010

Primary Completion Date

March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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: Double Blind (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):409-16. 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

Enrollment ^ICMJE

431

Completion Date

March 2012

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

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

Plan to Share Data

Not Provided

IPD Description

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

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