Clinical trial NCT01238978: Phase 4 Study in the Elderly Patients With T2DM
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Elderly
Keywords: Diabetes mellitus, vildagliptin, hypoglycemia, elderly
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 24 weeks
Secondary outcomes:
measure: Percent of patients reaching their therapeutic goal
timeFrame: 24 weeks
measure: Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal
timeFrame: 24 weeks
measure: Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Armentieres
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Caen
country: France
facility: Novartis Investigative Site
city: Creil
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site #2
city: Paris
country: France
facility: Novartis Investigative Site
city: Pau
country: France
facility: Novartis Investigative Site
city: St Jean de la Ruelle
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tours
country: France
facility: Novartis Investigative Site
city: Venissieux
country: France
facility: Novartis Investigative Site
city: Venissieux
country: France
facility: Novartis Investigative Site #2
city: Versailles
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.