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

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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)

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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