Phase 4 Study in the Elderly Patients With T2DM

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01238978

Acronym

GLYCEMIA

Enrollment

Registered

2010-11-11

Start date

2010-10-31

Completion date

2011-12-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, vildagliptin, hypoglycemia, elderly

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

Interventions

DRUGVildagliptin

DRUGUsual Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

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/

Design outcomes

Primary

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.	24 weeks

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026