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

December 6, 2010
December 14, 2012
December 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01257451 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
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)

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Vildagliptin
    vildagliptin 50mg bid
  • Drug: Placebo
    Placebo 50mg bid
  • Experimental: Vildagliptin
    Intervention: Drug: Vildagliptin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.
 
Completed
431
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovakia,   Belgium,   Bulgaria,   Finland,   Germany,   United Kingdom,   Spain
 
NCT01257451
CLAF237A23150, 2010-022658-18
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Corporation Novartis Pharmaceuticals
Novartis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP