Diabetes Mellitus, Type 2Phase 1NCT00551564
Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate
A Phase 1 study testing rosiglitazone maleate in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- rosiglitazone maleate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2007to 8 Sep 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and/or females aged 18-65 years
- Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.
- Healthy normal or overweight control subjects or healthy obese subjects or subjects with T2DM.
Who cannot join
- Clinically significant past or current medical conditions
- Clinically significant abnormalities in vital signs or routine laboratory parameters
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Chula Vista, California, 91911
About this study
Official title: A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose.
A major problem with the use of IR as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. The current 'gold standard' methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly. Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may be less accurate and are not widely accepted.
Read the detailed description
A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- rosiglitazone maleate
- Keywords
- total body water, T2DM,, Healthy Obese,, Insulin Resistance,, Rosiglitazone maleate,, Glucose Disposal,, hyperinsulinemic-euglycemic clamp,
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazone maleateDrug
Rosiglitazone tablets 4 mg dose will be administered orally by subjects
| Study group | Role | What they receive |
|---|---|---|
| Subjects in healthy normal and overweight control arm | Experimental | Subjects in the Healthy Normal or Overweight Control Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily. Receives: Drug: rosiglitazone maleate |
| Subjects in healthy obese with T2DM arm | Experimental | Subjects who are in the Healthy Obese or T2DM Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily. Receives: Drug: rosiglitazone maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Measured: baseline and after 8 weeks of Rosiglitazone treatment
Secondary outcomes (3)
Insulin resistance
Measured: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment
hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance
Measured: baseline, after 8 weeks treatment
Body composition
Measured: baseline & after 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study start31 Jul 2007
- Primary completion8 Sep 2008
- Study completion8 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
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
- NCT00551564
- Sponsor's protocol ID
- DIX110434
- Status last verified
- Aug 2017
- First submitted
- 29 Oct 2007
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT00551564
- Acronym / sponsor ID
- DIX110434
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- total body water, T2DM,, Healthy Obese,, Insulin Resistance,, Rosiglitazone maleate,, Glucose Disposal,, hyperinsulinemic-euglycemic clamp,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2007 (actual)
- Primary completion
- 8 Sep 2008 (actual)
- Study completion
- 8 Sep 2008 (actual)
- First posted
- 31 Oct 2007 (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.
Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose.
A major problem with the use of IR as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. The current 'gold standard' methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly. Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may be less accurate and are not widely accepted.
Detailed description
A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects in healthy normal and overweight control arm | Experimental | Drug: rosiglitazone maleateSubjects in the Healthy Normal or Overweight Control Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily. |
| Subjects in healthy obese with T2DM arm | Experimental | Drug: rosiglitazone maleateSubjects who are in the Healthy Obese or T2DM Population will be included in this arm and they will receive Rosiglitazone 4 milligram twice daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or females aged 18-65 years
- Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.
- Healthy normal or overweight control subjects or healthy obese subjects or subjects with T2DM.
Key exclusion criteria (2 listed)
- Clinically significant past or current medical conditions
- Clinically significant abnormalities in vital signs or routine laboratory parameters
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 |
|---|---|---|
| rosiglitazone maleateRosiglitazone tablets 4 mg dose will be administered orally by subjects | Drug | Subjects in healthy normal and overweight control arm, Subjects in healthy obese with T2DM arm |
Primary outcome
Insulin resistance
Time frame: baseline and after 8 weeks of Rosiglitazone treatment
3 secondary outcomes
Insulin resistance
Time frame: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment
hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance
Time frame: baseline, after 8 weeks treatment
Body composition
Time frame: baseline & after 8 weeks treatment
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 Aug 2017.
- BackgroundThis study has not been published in the scientific literature.
- Results for study DIX110434 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rosiglitazone maleate in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
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 3 inclusion and 2 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Insulin resistance (time frame: baseline and after 8 weeks of Rosiglitazone treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551564, which also lists 1 linked publication.
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 Aug 2017.