Trial · NCT02202161
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 |
| PRIMARY | Change From Baseline in Vital Signs Assessments-heart Rate | Baseline (pre-dose Day -1) and Day 7, 15 | Safety population. Only those participants available at the specified time points were analyzed. | Beats per minute | MEAN |
| PRIMARY | Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14 | Up to Day 15 (administered after every in-house bowel movement) | Safety population | Count of bowel movements | MEAN |
| PRIMARY | Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14 | Up to Day 15 (administered after every in-house bowel movement) | Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the Number of Participants Analyzed represents the number of participants reporting that rating not the number evaluated. | Events | NUMBER |
| PRIMARY | Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels) | Day 7 and 14 | Safety population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding | Up to Day 15 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed. | Nanograms per milliliter (ng/mL) | GEOMETRIC_LEAST_SQUARES_MEAN |
| SECONDARY | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | PK population. Only those participants available at the specified time points were analyzed. | Hour | MEDIAN |
| SECONDARY | PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10]) | Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14 | PK population. Only those participants available at the specified time points were analyzed. | Hour×ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides | Baseline (pre-dose Day -1) and Day 7, 14 | Safety population. Only those participants available at the specified time points were analyzed. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Ratio to Baseline in Fasting Apolipoprotein B | Baseline (pre-dose Day -1) and Day 7, 14 | Safety population | Ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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