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

February 21, 2017 updated by: Novartis

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
      • Paris, France, 75012
        • Novartis Investigative Site #2
      • 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
      • Venissieux, France
        • Novartis Investigative Site #2
      • Versailles, France, 78000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237AFR03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Vildagliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe