Diabetes Mellitus, Type 2Phase 3NCT00432679

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

A Phase 3 study testing Rosiglitazone (BRL49653C) in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Rosiglitazone (BRL49653C)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 4 sitesin 2 countries
Study dates: 24 May 2006to 28 Mar 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Who cannot join

Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Japan3 sites

GSK Investigational Site
Kanagawa, 212-0024
GSK Investigational Site
Kumamoto, 862-0976
GSK Investigational Site
Ōita, 870-0039

Other trials in Japan

Location not given1 site

GSK Investigational Site

About this study

Official title: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Conditions: Diabetes Mellitus, Type 2
Being tested: Rosiglitazone (BRL49653C)
Keywords: rosiglitazone, Avandia, type 2 diabetes mellitus, diabetes
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rosiglitazone (BRL49653C)Drug
study drug

Study groups in NCT00432679
Study group	Role	What they receive
arm 1	Experimental	study drug Receives: Drug: Rosiglitazone (BRL49653C)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).
Measured: Baseline (Day 0) and Week 16

Secondary outcomes (8)

Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Adiponectin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Measured: Baseline (Day 0) and Week 16
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.
Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 200628 Mar 2007

First posted8 Feb 2007 (estimated)
Study start24 May 2006
Primary completion28 Mar 2007
Study completion28 Mar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00432679
Sponsor's protocol ID: AVD105248
Status last verified: Nov 2022
First submitted: 6 Feb 2007
Last updated: 12 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

This study has not been published in the scientific literature.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients With Type 2 Diabetes Mellitus (Combination Therapy With Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -
ClinicalTrials.gov ID: NCT00432679
Acronym / sponsor ID: AVD105248
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone, Avandia, type 2 diabetes mellitus, diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 24 May 2006 (actual)
Primary completion: 28 Mar 2007 (actual)
Study completion: 28 Mar 2007 (actual)
First posted: 8 Feb 2007 (estimated)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
arm 1	Experimental	Drug: Rosiglitazone (BRL49653C)study drug

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Key exclusion criteria (1 listed)

Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

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 (BRL49653C)study drug	Drug	arm 1

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
Time frame: Baseline (Day 0) and Week 16
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).

8 secondary outcomes

Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Adiponectin
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline (Day 0) and Week 16
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
Time frame: Up to Week 16

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosiglitazone 4 mg Orally Once Daily	74	69
Placebo	75	72

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group

Time frame: Baseline (Day 0) and Week 16. Mean (Standard Deviation). Unit: Percentage of Glycosylated Hemoglobin

Measure	Rosiglitazone 4 mg Orally Once Daily n = 74	Placebo n = 75
Value	-0.62 (0.074)	0.19 (0.073)

Rosiglitazone 4 mg Orally Once Daily vs Placebo: Mean Difference (Net): -0.81 (95% CI -1.01 to -0.61), p <0.001, ANCOVA

Population analysed: Full analysis set used.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosiglitazone 4 mg Orally Once Daily	1 of 74 (1.4%)	61 of 74 (82.4%)	0 of 74
Placebo	1 of 75 (1.3%)	53 of 75 (70.7%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundThis study has not been published in the scientific literature.
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: No

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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

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosiglitazone (BRL49653C) in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in 2 countries.

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 1 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group (time frame: Baseline (Day 0) and Week 16). 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 NCT00432679, 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 12 Dec 2022.