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Trial record 20 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00575159
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: GSK189075
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 10 participants with type 1 diabetes mellitus (T1DM) were randomized in this study. Study was conducted between 31 Mach 2008 to 19 January 2009 at a single center in the United States (US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened within 28 days of the first dose and a total of 10 participants were randomized to receive the study drug. The participants were admitted on Day -2 and were analyzed of all Baseline safety and glucose control on Day -1.

Reporting Groups
  Description
Overall Study Arm Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 milligram (mg) tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant’s usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.

Participant Flow:   Overall Study
    Overall Study Arm
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study Arm Participants received 5 treatments P0, P1, A, B, C in each of the treatment period in a randomized manner separated by a 5 to 35-day washout period between treatments, where Treatment P0 consisted of Basal insulin [continuous subcutaneous insulin injection (CSII)], mealtime placebo injection, and placebo tablet. Treatment P1 consisted of CSII, mealtime bolus insulin injection, and Placebo tablet. Treatment A consisted of CSII, mealtime placebo injection, GSK189075 50 mg tablet. Treatment B consisted of CSII, mealtime placebo injection, GSK189075 150 mg tablet. Treatment C consisted of CSII, mealtime placebo injection, GSK189075 500 mg tablet. The two placebo sessions (P0 and P1) were designed to provide information about the relative efficacy of GSK189075 versus each individual participant’s usual mealtime insulin bolus. The number of tablets administered will be same for each treatment arm.

Baseline Measures
   Overall Study Arm 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.9  (8.08) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  30.0% 
Male      7  70.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      10 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 6 months ]

2.  Primary:   Number of Participants With Hypoglycemia Episodes/Events   [ Time Frame: Day 1 of each treatment period ]

3.  Primary:   Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)   [ Time Frame: Day 1 of each treatment period ]

4.  Primary:   Change From Baseline Vital Signs: Heart Rate   [ Time Frame: Day 1 of each treatment period ]

5.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Day 1 of each treatment period ]

6.  Primary:   Number of Participants With Abnormal Clinical Chemistry Data   [ Time Frame: Day 1 of each treatment period ]

7.  Primary:   Number of Participants With Abnormal Hematology Data   [ Time Frame: Day 1 of each treatment period ]

8.  Primary:   Summary of Urine Osmolality   [ Time Frame: Day 1 (pre dose) of each treatment period ]

9.  Primary:   Mean Creatinine Clearance   [ Time Frame: Up to 24 hours post dose of each treatment period. ]

10.  Primary:   Summary of Fluid Balance   [ Time Frame: Up to 24 hours post dose of each treatment period. ]

11.  Primary:   Mean of Derived Plasma Glucose Parameters   [ Time Frame: Up to 24 hours post dose of each treatment period. ]

12.  Secondary:   Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1   [ Time Frame: Up to 24 hours post dose of each treatment period. ]

13.  Secondary:   Urinary Glucose Excretion (UGE) for Timed Subintervals up to 24 Hours Post Dose (0-24 H)   [ Time Frame: Up to 24 hours post dose of each treatment period ]

14.  Secondary:   Percent of Filtered Glucose in the Urine.   [ Time Frame: Up to 24 hours post dose of each treatment period. ]

15.  Secondary:   Mean Total Urine Volume 0-24 H   [ Time Frame: Day 1 of each treatment period ]

16.  Secondary:   Mean Creatinine Clearance 0-24 H   [ Time Frame: Day 1 of each treatment period ]

17.  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   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

18.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of GSK189075 Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

19.  Secondary:   Time to Maximum Observed Plasma Concentration (Tmax) and Terminal Half Life, (T1/2) of GSK189075 Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

20.  Secondary:   AUC From Time Zero to 4 Hours Post Dose, AUC(0-4) for GSK189074 Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

21.  Secondary:   Oral Clearance (CL/F) Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

22.  Secondary:   The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK189074 Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]

23.  Secondary:   The Metabolite to Parent AUC Ratio, AUCmetabolite/AUCparent Ratio for GSK279782 Over Period   [ Time Frame: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00575159     History of Changes
Other Study ID Numbers: KGI107465
First Submitted: December 14, 2007
First Posted: December 18, 2007
Results First Submitted: August 1, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017