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

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ClinicalTrials.gov Identifier: NCT01238978
Recruitment Status : Completed
First Posted : November 11, 2010
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Elderly Drug: Vildagliptin Drug: "Usual Care" Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin Drug: Vildagliptin
Active Comparator: other Oral Antidiabetic Drug in a different therapeutic class Drug: "Usual Care"

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percent of patients reaching their therapeutic goal [ Time Frame: 24 weeks ]
  2. Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal [ Time Frame: 24 weeks ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238978

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 #2
Paris, France, 75012
Novartis Investigative Site
Paris, France, 75020
Novartis Investigative Site
Pau, France, 64000
Novartis Investigative Site
St Jean de la Ruelle, France, 45140
Novartis Investigative Site
Strasbourg, France, 67000
Novartis Investigative Site
Strasbourg, France
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01238978     History of Changes
Other Study ID Numbers: CLAF237AFR03
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs