Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride (GLOBE)

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypoglycemia; Type 2 Diabetes

Treatments: Drug: Metformin; Drug: glimepiride; Drug: vildagliptin and metformin (combination)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02007278

CLAF237ACO01

Details and patient eligibility

About

The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• HbA1c between 8%-10.5% in stable metformin dose (>1500 mg/day), four weeks prior visit 1

Key Exclusion Criteria:

• Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

vildagliptin and metformin

Active Comparator group

Description:

Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks

Treatment:

Drug: vildagliptin and metformin (combination)

glimepiride and metformin

Active Comparator group

Description:

Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Treatment:

Drug: glimepiride

Drug: Metformin