Trial · NCT01262898

Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis

NCT01262898, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-10-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis. Trials, record NCT01262898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01262898

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
NCT number: NCT01262898
Status: Completed
Phases: Phase 2
Enrollment: 79 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Gastroparesis
Interventions: GSK962040 (5 mg tablet), GSK962040 (25 mg tablet), GSK962040 (125 mg tablet), Placebo
First posted: 2010-12-17
Last updated: 2021-07-15
Other registries' IDs: eudract:2010-023186-21
Results first posted: 2017-10-13

Source ClinicalTrials.gov

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Gastric Half Emptying Time (GEt1/2)	Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28	Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes(min) later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.
Secondary	Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)	Up to follow-up (5-10 days post last dose)	An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Data for on-treatment adverse events is reported.
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position	Baseline, Day 1, and Day 8	Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Secondary	Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position	Baseline, Day 1, and Day 8	Heart rate measurements were taken at pre-dose and 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values . Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Secondary	Change From Baseline in Electrocardiography Parameters (12-lead ECG)	Baseline, Day 1 and Day 28	ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The Baseline value was the Day 1 pre-dose value. ECG parameters included PR interval, QRS duration, QT interval, QTcB, QTcF and RR interval.
Secondary	Number of Participants Outside the Normal Range for SBP and DBP	Screening2/Baseline (Day -30 to -1), Day 1 and 28	Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The clinical concern range (CCR) for SBP was greater than (\<) 85 and less than (\>) 160 and for DBP the range was \<45 and \>100. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.
Secondary	Number of Participants Outside the Normal Range for Heart Rate	Screening2/Baseline (Day -30 to -1), Day 1 and 28	Heart rate measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The CCR for heart rate was Increase or decrease by less than or equal to (\>=) 15 and \>= 30. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.
Secondary	Number of Participants Outside the Normal Range for 12-lead ECG	Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28	ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The CCR for ECG parameters were: PR interval (\<110 and \>220), QRS interval (\<75 and \>110), Absolute QTc interval (\>450 to =\< 480) respectively. Baseline was the pre-dose reading for Day 1. Data for abnormal- clinically significant (ACS) and abnormal- not clinically significant (ANCS) has been presented.
Secondary	Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase	Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28	Alkaline phosphatase, alanine amino transferase, aspartate amino transferase, gamma glutamyl transferase, creatine kinase, lactate dehydrogenase measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Secondary	Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid	Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28	Direct Bilirubin, Total Bilirubin, Creatinine, Uric acid measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.

1 to 10 of 30Source ClinicalTrials.gov

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Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Gastric Half Emptying Time (GEt1/2)	Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28	The 'All Subjects Population' compromised of all participants who received at least one dose of study medication. Only those participants available at specified time points were analyzed.	Minutes	MEAN
SECONDARY	Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)	Up to follow-up (5-10 days post last dose)	All Subjects population.	Participants	NUMBER
SECONDARY	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position	Baseline, Day 1, and Day 8	All Subjects Population. Only those participants available at specified time points were analyzed.	Millimeters of mercury (mmHg)	MEAN
SECONDARY	Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position	Baseline, Day 1, and Day 8	All Subjects Population. Only those participants available at specified time points were analyzed.	Beats per minute (BPM)	MEAN
SECONDARY	Change From Baseline in Electrocardiography Parameters (12-lead ECG)	Baseline, Day 1 and Day 28	All Subjects Population. Only those participants available at specified time points were analyzed.	Milliseconds (msec)	MEAN
SECONDARY	Number of Participants Outside the Normal Range for SBP and DBP	Screening2/Baseline (Day -30 to -1), Day 1 and 28	All Subjects Population. Only those participants available at specified time points were analyzed.	Participants	NUMBER
SECONDARY	Number of Participants Outside the Normal Range for Heart Rate	Screening2/Baseline (Day -30 to -1), Day 1 and 28	All Subjects Population. Only those participants available at specified time points were analyzed.	Participants	NUMBER
SECONDARY	Number of Participants Outside the Normal Range for 12-lead ECG	Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28	All Subjects Population. Only those participants available at specified time points were analyzed.	Participants	NUMBER
SECONDARY	Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase	Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28	All Subjects Population. Only those participants available at specified time points were analyzed.	International units per liter (IU/L)	MEAN
SECONDARY	Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid	Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28	All Subjects Population. Only those participants available at specified time points were analyzed.	Unit moles per litre (UMOL/L)	MEAN

1 to 10 of 30Source ClinicalTrials.gov

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Results by group604

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Gastric Half Emptying Time (GEt1/2)	Placebo	Baseline	131.2	Standard Deviation 25.31	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 10 mg	Baseline	106.5	Standard Deviation 23.42	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 50 mg	Baseline	118.2	Standard Deviation 31.13	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 125 mg	Baseline	131.1	Standard Deviation 32.66	Minutes
Gastric Half Emptying Time (GEt1/2)	Placebo	Day 1	124.1	Standard Deviation 39.25	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 10 mg	Day 1	106.6	Standard Deviation 27.07	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 50 mg	Day 1	104.8	Standard Deviation 21.61	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 125 mg	Day 1	99.4	Standard Deviation 33.55	Minutes
Gastric Half Emptying Time (GEt1/2)	Placebo	Day 28	111.8	Standard Deviation 24.37	Minutes
Gastric Half Emptying Time (GEt1/2)	GSK962040 10 mg	Day 28	111.8	Standard Deviation 32.23	Minutes

1 to 10 of 604Source ClinicalTrials.gov

See all 604 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	21
Overall Study	STARTED	GSK962040 10 mg	18
Overall Study	STARTED	GSK962040 50 mg	18
Overall Study	STARTED	GSK962040 125 mg	22
Overall Study	COMPLETED	Placebo	18
Overall Study	COMPLETED	GSK962040 10 mg	16
Overall Study	COMPLETED	GSK962040 50 mg	18
Overall Study	COMPLETED	GSK962040 125 mg	22
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	GSK962040 10 mg	2

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events188

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Placebo	4	21	5
other	Headache	Nervous system disorders	GSK962040 10 mg	2	18	3
other	Headache	Nervous system disorders	GSK962040 50 mg	4	18	6
other	Headache	Nervous system disorders	GSK962040 125 mg	6	22	9
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	21	3
other	Diarrhoea	Gastrointestinal disorders	GSK962040 10 mg	4	18	5
other	Diarrhoea	Gastrointestinal disorders	GSK962040 50 mg	3	18	4
other	Diarrhoea	Gastrointestinal disorders	GSK962040 125 mg	3	22	3
other	Nausea	Gastrointestinal disorders	Placebo	1	21	1
other	Nausea	Gastrointestinal disorders	GSK962040 10 mg	4	18	4

1 to 10 of 188Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	21
Total, all-cause mortality	GSK962040 10 mg	0	18
Total, all-cause mortality	GSK962040 50 mg	0	18
Total, all-cause mortality	GSK962040 125 mg	0	22
Total, other adverse events	Placebo	11	21
Total, other adverse events	GSK962040 10 mg	14	18
Total, other adverse events	GSK962040 50 mg	14	18
Total, other adverse events	GSK962040 125 mg	14	22
Total, serious adverse events	Placebo	1	21
Total, serious adverse events	GSK962040 10 mg	0	18

1 to 10 of 12Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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