Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients. (BENEFIT)

Novartis

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LAF237; Drug: Protaphane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649466

2012-001143-46 (EudraCT Number)

CLAF237ADE08

Details and patient eligibility

About

This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.

Enrollment: 162 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of type 2 diabetes mellitus.
• Contraindicated or intolerant to take metformin.
• HbA1c of ≥ 7.0% and ≤ 8.5%
• Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion criteria

• Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
• Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
• Patients taking sulfonylurea for longer than 5 years
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
• pregnancy
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Vildagliptin

Experimental group

Description:

Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.

Treatment:

Drug: LAF237

Protaphane

Active Comparator group

Description:

Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.

Treatment:

Drug: Protaphane