Diabetes Mellitus, Type 2AVANDAMETPMSNCT01294553

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010

An observational study of Diabetes Mellitus, Type 2, run by GlaxoSmithKline.

Completed

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

Trial summary

An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information Read more about this study

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Administration of rosiglitazone/metformin
How many people: 717 participants
Where: No sites listed yet
Study dates: Jun 2004to Jan 2010
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Type II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital

Who may be able to join

Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus
Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
Subjects administered with rosiglitazone/metformin following the locally approved prescribing information

Who cannot join

Subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient
Subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset
Subjects with type 1 diabetes mellitus
Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
Subjects with severe infection, pre/post surgery, severe trauma
Subjects with malnutrition, inanition, emaciation, pituitary insufficiency, adrenal insufficiency
Subjects undergoing radiologic studies involving intravascular administration of iodinated contrast materials

About this study

Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information

Read the detailed description

Conditions: Diabetes Mellitus, Type 2
Being tested: Administration of rosiglitazone/metformin
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.

Administration of rosiglitazone/metforminDrug
Also called according to label and physician's decision based on each subject's condition
Subjects who are administered rosiglitazone/metformin at least once

Study groups in NCT01294553
Study group	Role	What they receive
rosiglitazone/metformin group		Korean subjects who are administered rosiglitazone/metformin according to the prescription information Receives: Drug: Administration of rosiglitazone/metformin

What is being measured

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

Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Measured: 41.4 weeks

Secondary outcomes (2)

Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Measured: 41.4 weeks
Number of Participants With the Indicated Unexpected Adverse Events
Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.
Measured: 41.4 weeks

Timeline

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

Jun 2004Jan 2010

First posted11 Feb 2011 (estimated)
Study startJun 2004
Primary completionJan 2010
Study completionJan 2010

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.
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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 717 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294553
Sponsor's protocol ID: 105709
Acronym: AVANDAMETPMS
Status last verified: Feb 2011
First submitted: 10 Feb 2011
Last updated: 7 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information
ClinicalTrials.gov ID: NCT01294553
Acronym / sponsor ID: AVANDAMETPMS / 105709
Conditions: Diabetes Mellitus, Type 2
Study type: Observational
Recruitment status: Completed
Enrolment: 717 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 11 Feb 2011 (estimated)
Results: Posted 15 Mar 2011

Clinical summary

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

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
rosiglitazone/metformin group	–	Drug: Administration of rosiglitazone/metforminKorean subjects who are administered rosiglitazone/metformin according to the prescription information

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Type II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital

Key inclusion criteria (3 listed)

Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus
Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen
Subjects administered with rosiglitazone/metformin following the locally approved prescribing information

Key exclusion criteria (7 listed)

Subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient
Subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset
Subjects with type 1 diabetes mellitus
Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
Subjects with severe infection, pre/post surgery, severe trauma

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
Administration of rosiglitazone/metforminAlso: according to label and physician's decision based on each subject's conditionSubjects who are administered rosiglitazone/metformin at least once	Drug	rosiglitazone/metformin group

Primary outcome

Number of Participants With an Adverse Event
Time frame: 41.4 weeks
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.

2 secondary outcomes

Number of Participants With a Serious Adverse Event
Time frame: 41.4 weeks
Number of Participants With the Indicated Unexpected Adverse Events
Time frame: 41.4 weeks

Results and safety

Results posted to the registry on 15 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg	982	713

Primary outcome: Number of Participants With an Adverse Event

Time frame: 41.4 weeks. Number. Unit: participants

Measure	Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg n = 713
Value	110

Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg: Percentage of participants: 15.4 (95% CI 12.8 to 18.1)

Population analysed: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg	2 of 713 (0.3%)	77 of 713 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Type 2

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

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?

An observational study of 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 3 inclusion and 7 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 7 Jul 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2011). 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?

Number of Participants With an Adverse Event (time frame: 41.4 weeks). 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 NCT01294553.

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 7 Jul 2017.