Type 2 Diabetes MellitusPhase 1NCT00259896
In-patient Study in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing exenatide in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- exenatide
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- must not have any other major illness other than diabetes
About this study
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
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.
- Being tested
- exenatide
- Keywords
- exenatide, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic measurements during 7 days of dosing.
Secondary outcomes (1)
Pharmacokinetic measurements during 7 days of dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259896
- Sponsor's protocol ID
- GLP105330
- Status last verified
- Jan 2011
- First submitted
- 30 Nov 2005
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00259896
- Acronym / sponsor ID
- GLP105330
- Keywords
- exenatide, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- must not have any other major illness other than diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exenatide | Drug | – |
Primary outcome
Pharmacodynamic measurements during 7 days of dosing.
1 secondary outcome
Pharmacokinetic measurements during 7 days of dosing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exenatide in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic measurements during 7 days of dosing.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.