Phase 4 Study in the Elderly Patients With T2DM

Type 2 Diabetes Mellitus Clinical Trial

— GLYCEMIA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238978
• Other study ID #: CLAF237AFR03
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2010
• Last updated: February 21, 2017
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Elderly
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin

• "Usual Care"

Locations

Country	Name	City	State
France	Novartis Investigative Site	Armentieres
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Caen
France	Novartis Investigative Site	Creil
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site #2	Paris
France	Novartis Investigative Site	Pau
France	Novartis Investigative Site	St Jean de la Ruelle
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Tours
France	Novartis Investigative Site	Venissieux
France	Novartis Investigative Site #2	Venissieux
France	Novartis Investigative Site	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

France, 

References & Publications (1)

Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 weeks
Secondary	Percent of patients reaching their therapeutic goal		24 weeks
Secondary	Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal		24 weeks
Secondary	Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks.		24 weeks

External Links

•   Results from CLAF237AFR03 from the Novartis Clinical Trials website