Trial · NCT02202161
A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients
NCT02202161, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients. Trials, record NCT02202161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02202161
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients
- NCT number
- NCT02202161
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- GSK2330672, Placebo, Sitagliptin, Metformin
- First posted
- 2014-07-28
- Last updated
- 2017-11-06
- Results first posted
- 2017-11-06
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours) | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment. |
| Primary | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 14 days (treatment period) | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) \>= 3× upper limit of normal (ULN) and total bilirubin \>=2 × ULN (\>35% direct) or ALT \>=3 × ULN and international normalized ratio \>1.5. |
| Primary | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | Up to Day 15 | Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. |
| Primary | Number of Participants With Abnormal Clinical Chemistry With PCI | Up to Day 15 | Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: \>=2×upper limit of normal \[ULN\]); AST (NR: 0-40; PCI: \>=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: \>=1.5× ULN). |
| Primary | Number of Participants With Abnormal Urinalysis Data | Baseline (pre-dose Day -1), Day 7 and 15 | Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, \>30, WBC: none seen, 0-5, 1, 2, 4, \<5, 6-10, 11-30, 19, \>30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality. |
| Primary | Summary of Urinalysis Data-mean Specific Gravity | Baseline (pre-dose Day -1), Day 7 and 15 | Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020. |
| Primary | Summary of Urinalysis Data-mean pH | Baseline (pre-dose Day -1), Day 7 and 15 | Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Up to Day 15 | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented. |
| Primary | Change From Baseline in Vital Signs Assessments-temperature | Baseline (pre-dose Day -1) and, Day 7, 15 | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. |
| Primary | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (pre-dose Day -1) and Day 7, 15 | The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours) | Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed. | Mg/deciliter | MEAN |
| PRIMARY | Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 14 days (treatment period) | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI) | Up to Day 15 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Chemistry With PCI | Up to Day 15 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Urinalysis Data | Baseline (pre-dose Day -1), Day 7 and 15 | Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary of Urinalysis Data-mean Specific Gravity | Baseline (pre-dose Day -1), Day 7 and 15 | Safety population. Only those participants available at the specified time points were analyzed. | Ratio | MEAN |
| PRIMARY | Summary of Urinalysis Data-mean pH | Baseline (pre-dose Day -1), Day 7 and 15 | Safety population. Only those participants available at the specified time points were analyzed. | Unit on a scale | MEAN |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline | Up to Day 15 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Vital Signs Assessments-temperature | Baseline (pre-dose Day -1) and, Day 7, 15 | Safety population. Only those participants available at the specified time points were analyzed. | Degree Celsius | MEAN |
| PRIMARY | Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (pre-dose Day -1) and Day 7, 15 | Safety population. Only those participants available at the specified time points were analyzed. | Millimeters of mercury | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group1,071
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Placebo | Fasting, Day 7 | -6.58 | Standard Deviation 16.357 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 10 mg BID | Fasting, Day 7 | -8.25 | Standard Deviation 6.500 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 20 mg BID | Fasting, Day 7 | -1.40 | Standard Deviation 23.050 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 30 mg BID | Fasting, Day 7 | -38.56 | Standard Deviation 24.744 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 60 mg BID | Fasting, Day 7 | -34.38 | Standard Deviation 19.398 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 90 mg BID | Fasting, Day 7 | -24.78 | Standard Deviation 13.414 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Sitagliptin 50 mg BID | Fasting, Day 7 | -24.54 | Standard Deviation 33.955 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | Placebo | Fasting, Day 14 | -10.00 | Standard Deviation 19.207 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 10 mg BID | Fasting, Day 14 | -22.75 | Standard Deviation 11.354 | Mg/deciliter |
| Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour]) | GSK2330672 20 mg BID | Fasting, Day 14 | -16.20 | Standard Deviation 28.709 | Mg/deciliter |
1 to 10 of 1,071Source ClinicalTrials.gov
See all 1,071 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 13 | |
| Overall Study | STARTED | GSK2330672 10 mg BID | 5 | |
| Overall Study | STARTED | GSK2330672 20 mg BID | 5 | |
| Overall Study | STARTED | GSK2330672 30 mg BID | 9 | |
| Overall Study | STARTED | GSK2330672 60 mg BID | 9 | |
| Overall Study | STARTED | GSK2330672 90 mg BID | 10 | |
| Overall Study | STARTED | Sitagliptin 50 mg BID | 13 | |
| Overall Study | STARTED | Run-in Only | 6 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | GSK2330672 10 mg BID | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events315
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 | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK2330672 10 mg BID | 2 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK2330672 20 mg BID | 5 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK2330672 30 mg BID | 2 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK2330672 60 mg BID | 7 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | GSK2330672 90 mg BID | 6 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Sitagliptin 50 mg BID | 2 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 10 mg BID | 1 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 20 mg BID | 2 | 5 |
1 to 10 of 315Source ClinicalTrials.gov
See all 315 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 13 |
| Total, all-cause mortality | GSK2330672 10 mg BID | 0 | 5 |
| Total, all-cause mortality | GSK2330672 20 mg BID | 0 | 5 |
| Total, all-cause mortality | GSK2330672 30 mg BID | 0 | 9 |
| Total, all-cause mortality | GSK2330672 60 mg BID | 0 | 9 |
| Total, all-cause mortality | GSK2330672 90 mg BID | 0 | 10 |
| Total, all-cause mortality | Sitagliptin 50 mg BID | 0 | 13 |
| Total, other adverse events | Placebo | 9 | 13 |
| Total, other adverse events | GSK2330672 10 mg BID | 3 | 5 |
| Total, other adverse events | GSK2330672 20 mg BID | 5 | 5 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02202161
GET https://conductscience.org/api/trials/v1/NCT02202161/registered?page=2