Last updated: 11/04/2018 07:55:54
In-patient study in patients with Type 2 Diabetes Mellitus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, open-label, placebo-controlled, repeat-dose study to assess the pharmacokinetics and pharmacodynamics of 5 micrograms exenatide administered subcutaneously twice daily for 7 days in healthy normal volunteers and in subjects with Type 2 Diabetes Mellitus
Trial description: This study is a placebo-controlled study in both healthy normal subjects and patients with Type 2 Diabetes Mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. Assessments include repeat blood sampling and monitoring of any side effects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: exenatide
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
albiglutide
Collaborators
Not applicable
Study date(s)
October 2005 to January 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 66 years
Accepts healthy volunteers
Yes
- have type 2 diabetes mellitus that has been diagnosed for at least three months
- must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea
- must not have any other major illness other than diabetes
Inclusion and exclusion criteria
Inclusion criteria:
- have type 2 diabetes mellitus that has been diagnosed for at least three months
- must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea
- must be willing to wash-out of these medications for 14 days prior to the start of the study
- must have bloodwork that meets certain criteria (for example, total cholesterol < 240 mg/dL)
Exclusion criteria:
- must not have any other major illness other than diabetes
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-26-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website