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Phase 4 Study in the Elderly Patients With T2DM (GLYCEMIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01238978
First received: November 9, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin


Condition Intervention Phase
Type 2 Diabetes Mellitus
Elderly
 Drug: Vildagliptin
Drug: "Usual Care"
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Open-label, Parallel Group Study to Investigate the Clinical Benefit on Hypoglycemia Frequency of 24 Weeks Treatment With Galvus Versus Usual Care (Any OAD of Another Class Added to Metformin Within SmPc) in Older Patients With Type 2 Diabetes Insufficiently Controlled by Metformin Monotherapy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of patients reaching their therapeutic goal [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: Vildagliptin
Active Comparator: other Oral Antidiabetic Drug in a different therapeutic class Drug: "Usual Care"

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus (DM) patients aged 65 to 80 years, willing to perform SMBG in case of symptomatic hypoglycemia.
  • HbA1c: 6.5 to 8.5 % with max tolerated dose of metformin monotherapy for at least 3 months.

Exclusion Criteria:

  • Age > 80 yrs
  • BMI < 22 and ≥ 45 kg/m2
  • Secondary T2 DM
  • Hepatic failure, moderate/severe renal failure (Cl < 50 ml/min) and CHF III & IV
  • ASAT / ALAT > 3 ULN, creatinine clearance < 50 ml/min Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238978

Locations
France
Novartis Investigative Site
Armentieres, France, 59208
Novartis Investigative Site
Brest, France, 29200
Novartis Investigative Site
Caen, France, 14000
Novartis Investigative Site
Creil, France, 60100
Novartis Investigative Site
Paris, France, 75020
Novartis Investigative Site #2
Paris, France, 75012
Novartis Investigative Site
Pau, France, 64000
Novartis Investigative Site
St Jean de la Ruelle, France, 45140
Novartis Investigative Site
Strasbourg, France
Novartis Investigative Site
Strasbourg, France, 67000
Novartis Investigative Site
Toulouse, France, 31200
Novartis Investigative Site
Tours, France, 37000
Novartis Investigative Site
Venissieux, France, 69200
Novartis Investigative Site #2
Venissieux, France
Novartis Investigative Site
Versailles, France, 78000
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01238978     History of Changes
Other Study ID Numbers: CLAF237AFR03
Study First Received: November 9, 2010
Last Updated: May 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
European Union: European Medicines Agency

Keywords provided by Novartis:
Diabetes mellitus, vildagliptin, hypoglycemia, elderly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
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 May 22, 2013