NCT01710527: BA/BE 173/11

BE Study of Metformin GSK 500mg

Completed Phase 2 Results posted Last updated 2 June 2017

What this trial tests

Phase 2 trial testing Metformin 500mg in Diabetic Foot in 32 participants. Completed in 18 May 2012.

Timeline

9 May 2012

Primary endpoint
18 May 2012

18 May 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	32
Start date	9 May 2012
Primary completion	18 May 2012
Estimated completion	18 May 2012

Drugs / interventions tested

• Metformin 500mg
• Glucophage 500mg

Conditions studied

• Diabetic Foot — all drugs for Diabetic Foot →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, male only, with Diabetic Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.

Group	Value	95% CI
Treatment T-Metformin 500 mg	962.728	± 246.0751
Treatment R- Glucophage 500 mg	985.257	± 223.1331

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity) Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal rule from measured data points from time of administration until the time of last quantifiable concentration. AUC0- infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant. The AUC0- infinity was the sum of the estimated and extrapolated parts.

AUC0-t

Group	Value	95% CI
Treatment T-Metformin 500 mg	7396.329	± 1869.1737
Treatment R- Glucophage 500 mg	7215.743	± 1865.2930

AUC0-infinity

Group	Value	95% CI
Treatment T-Metformin 500 mg	7577.176	± 1856.9193
Treatment R- Glucophage 500 mg	7400.540	± 1866.7596

Time of the Maximum Plasma Concentration (T-max) Over Period Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value.

Group	Value	95% CI
Treatment T-Metformin 500 mg	3.00	± 0.910
Treatment R- Glucophage 500 mg	3.00	± 0.991

Terminal Half-life (T-half) Over Period Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with elimination rate constant obtained as semi logarithmic plot of the plasma concentration versus time.

Group	Value	95% CI
Treatment T-Metformin 500 mg	3.84	± 0.511
Treatment R- Glucophage 500 mg	3.86	± 0.549

Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUC%_Extrapolated) Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC%\_Extrapolated was obtained by subtracting AUC0-t from AUC0-infinity divided by AUC0-infinity and multiplied by 100.

Group	Value	95% CI
Treatment T-Metformin 500 mg	2.604	± 1.5408
Treatment R- Glucophage 500 mg	2.684	± 1.6589

Apparent First-order Elimination or Terminal Rate Constant Primary · Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.

Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semi logarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.

Group	Value	95% CI
Treatment T-Metformin 500 mg	0.183	± 0.0250
Treatment R- Glucophage 500 mg	0.184	± 0.0285

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Secondary · Up to 38 days

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated w

Any AE

Group	Value	95% CI
Treatment T-Metformin 500 mg	2
Treatment R- Glucophage 500 mg	1

Any SAE

Group	Value	95% CI
Treatment T-Metformin 500 mg	0
Treatment R- Glucophage 500 mg	0

Number of Participants With Abnormal Vital Sign Results Secondary · Up to 38 days

Vital signs measurements (blood pressure, respiratory rate, pulse rate and oral temperature) were conducted during screening and during post study safety assessments. Vital signs measurement were also performed at each check-in and at checkout and were also recorded before dosing of study drug, between 2-3, 9-10 and 36.0 hour post-dose. Measurements were recorded in sitting position after rest of at least 5 min.

Group	Value	95% CI
Treatment T-Metformin 500 mg	0
Treatment R- Glucophage 500 mg	0

Number of Participants With Abnormal Periodic Physical Examination Results Secondary · Up to 38 days

Brief physical examination was performed at each check-in, check-out and complete physical examination during screening and at the end of the clinical part of the study.

Group	Value	95% CI
Treatment T-Metformin 500 mg	0
Treatment R- Glucophage 500 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AE's and SAE's were collected up to 38 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment T-Metformin 500 mg

Serious: 0/32 (0%)

Deaths: 0/32

Treatment R- Glucophage 500 mg

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (3 terms — click to expand)

Reaction	System	Treatment T-Metformin 500 mg	Treatment R- Glucophage 50…
Vomiting	Gastrointestinal disorders	—	—
Headache	General disorders	—	—
Tiredness	General disorders	—	—

Data from ClinicalTrials.gov NCT01710527 adverse events section.

Sponsor's own description

A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.

To demonstrate the bioequivalence of Metformin 500 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 500 mg tablets of MERCK SANTE in healthy adult human male subjects under fasting condition and to monitor the safety of the study subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.