Phase 4 Study in the Elderly Patients With T2DM

Phase 4

Completed

• Conditions: Elderly; Type 2 Diabetes Mellitus
• Interventions: Drug: "Usual Care"; Drug: Vildagliptin

• Registration Number: NCT01238978
• Lead Sponsor: Novartis

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
other Oral Antidiabetic Drug in a different therapeutic class	"Usual Care"	-
Vildagliptin	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Novartis Investigative Site #2; 🇫🇷 Venissieux, France

Novartis Investigative Site; 🇫🇷 Versailles, France