Phase 2
Completed N=10
A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00575159 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE) — 3; 4; 5; 6 Participants
Summary
The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE) |
3; 4; 5; 6; 4; 0 | — |
| PRIMARY Number of Participants With Hypoglycemia Episodes/Events |
5; 5; 3; 5; 6 | — |
| PRIMARY Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP) |
1.6; -5.1; -0.7; -3.4; -1.9; 1.8 | — |
| PRIMARY Change From Baseline Vital Signs: Heart Rate |
-1.4; -5.4; -4.5; -4.7; -5.2; 1.7 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) Findings |
0; 1; 1; 3; 0; 0 | — |
| PRIMARY Number of Participants With Abnormal Clinical Chemistry Data |
4; 5; 6; 6; 5; 1 | — |
| PRIMARY Number of Participants With Abnormal Hematology Data |
1; 0; 2; 1; 0; 5 | — |
| PRIMARY Summary of Urine Osmolality |
631.8; 651.6; 647.1; 618.3; 702.2; 330.5 | — |
| PRIMARY Mean Creatinine Clearance |
116.9; 134.5; 130.2; 142.2; 134.3; 111.5 | — |
| PRIMARY Summary of Fluid Balance |
1240.0; 1274.4; 1221.0; 1009.5; 1201.0; 4196.3 | — |
| PRIMARY Mean of Derived Plasma Glucose Parameters |
5.75639; 6.65953; 6.18659; 5.72419; 5.86796; 18.26279 | — |
| SECONDARY Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1 |
8.739; 4.480; 6.632; 6.044; 6.099; 10.535 | 0.0008 sig |
| SECONDARY Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H) |
324.849; 135.119; 579.060; 601.879; 770.249 | — |
| SECONDARY Percent of Filtered Glucose in the Urine. |
10.8661; 6.5576; 40.4788; 41.5290; 41.3449; 16.7543 | — |
| SECONDARY Mean Total Urine Volume 0-24 H |
4628.5; 4623.0; 5267.5; 4962.0; 5274.4 | — |
| SECONDARY Mean Creatinine Clearance 0-24 H |
113.6; 124.0; 120.9; 121.3; 128.2 | — |
| SECONDARY Area Under the Plasma Concentration vs. Time Curve (AUC) From Time Zero (Time of Dosing) to the Last Time Point With Measurable Analyte Concentration, AUC(0-last), AUC From Time Zero to Infinite Time, AUC(0-inf) of GSK189075 Over Period |
8.101; 25.922; 58.362; 3.966; 16.552; 47.390 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period |
5.266; 11.903; 39.029 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period |
0.446; 0.521; 1.054; 0.915; 1.019; 0.678 | — |
| SECONDARY AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period |
243.281; 700.970; 2038.298 | — |
| SECONDARY Oral Clearance (CL/F) Over Period |
2849.947; 2732.322; 2903.590 | — |
| SECONDARY The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period |
90.436; 67.801; 74.281 | — |
| SECONDARY The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period |
0.427; 0.442; 0.433 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male/female, 18 to 55 years old
- Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump
- Willing and able to follow all study-related instructions provided by the site staff.
- Willing to provide signed informed consent.
Exclusion Criteria
- Pregnant or a nursing female.
- Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
- Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.
- Have a history of alcohol abuse or have an eating disorder
- Have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.
Data sourced from ClinicalTrials.gov (NCT00575159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.