Phase 4 Study in the Elderly Patients With T2DM

Novartis46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Elderly

Interventions

VildagliptinDRUG

"Usual Care"DRUG

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (15)

Novartis Investigative Site

Armentières, France

Novartis Investigative Site

Brest, France

Novartis Investigative Site

Caen, France

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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