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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238978
First Posted: November 11, 2010
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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: 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.

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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 #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
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01238978     History of Changes
Other Study ID Numbers: CLAF237AFR03
First Submitted: November 9, 2010
First Posted: November 11, 2010
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
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs