NCT01725672

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers

Terminated Phase 1 Last updated 12 June 2017

What this trial tests

Phase 1 trial testing Metformin, 500 mg extended release tablet in Diabetes Mellitus, Type 2 in 20 participants. Terminated before completion.

Timeline

27 September 2012

Primary endpoint
21 August 2013

21 August 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	27 September 2012
Primary completion	21 August 2013
Estimated completion	21 August 2013
Sites	1 location across Australia

Drugs / interventions tested

• Metformin, 500 mg extended release tablet
• Metformin, 1000 mg extended release tablet — full drug profile →
• Glimepiride, 1 mg immediate release tablet — full drug profile →
• Glimepiride, 2 mg immediate release tablet — full drug profile →
• Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers
• Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers
• Metformin, 500 mg and Glimepiride, 1 mg extended release tablet coated with release controlling polymers
• Metformin, 1000 mg and Glimepiride, 2 mg extended release tablet coated with release controlling polymers

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a an open-label, randomized, single dose, four-way crossover, multi-stage study enrolling 20 healthy adult male and female subjects per part. This study consists of two separate parts (Part A and B) with each part comprising four treatment periods. Each subject will participate in all four treatment periods per part; Subjects may not enrol in both Parts A and B.

This study is being conducted to compare the pharmacokinetics (PK) of two extended release fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses, 500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single dose and compared with the commercially available formulations of metformin extended release (XR) (GLUCOPHAGE ™ Sustained Release \[SR\]) and glimepiride immediate release (IR) (AMARYL ™).

Part A of study will evaluate the bioavailability of a formulation comprising a film coated tablet containing release controlling polymers; and Part B will evaluate the bioavailability of a formulation comprising a tablet coated with release controlling polymers.

In each part there will be 4 treatment periods. During each period, subjects will be randomized sequentially to receive a single dose of a reference treatment of 500 mg metformin XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR; and an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR.Serial PK sampling for up to 36 hours and safety assessments will be performed. Each period will be separated by a washout period of at least 5 days and a follow-up visit will occur 14 days after the last dose of study drug.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.