Diabetes Mellitus, Type 2Phase 3NCT00069836
Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
A Phase 3 study testing Rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 93 sites in 5 countries.
Trial summary
This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone/metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 93 sitesin 5 countries
- Study dates
- Oct 2003to Nov 2004
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
- Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.
Who cannot join
- Patients cannot have any form of congestive heart failure or severe or unstable angina.
- Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.
Trial locations and contacts
93 sites in 5 countries.
93 sites in 5 countries
Germany51 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52070
GSK Investigational Site
Altenkirchen, Rhineland-Palatinate, 57610
GSK Investigational Site
Bad Kreuznach, Hesse, 55545
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Beckum, North Rhine-Westphalia, 59269
GSK Investigational Site
Berlin, State of Berlin, 10789
GSK Investigational Site
Berlin, State of Berlin, 12347
GSK Investigational Site
Berlin, State of Berlin, 12351
GSK Investigational Site
Berlin, State of Berlin, 13057
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51065
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Dresden, Saxony, 01219
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Falkensee, Brandenburg, 14612
GSK Investigational Site
Frankfurt am Main, Hesse, 60326
GSK Investigational Site
Freital, Saxony, 01705
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Gotha, Thuringia, 99867
GSK Investigational Site
Halberstadt, Saxony-Anhalt, 38820
GSK Investigational Site
Halle, Saxony-Anhalt, 06112
GSK Investigational Site
Halle, Saxony-Anhalt, 06114
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20246
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22041
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22607
GSK Investigational Site
Hermaringen, Baden-Wurttemberg, 89568
GSK Investigational Site
Hildesheim, Lower Saxony, 31139
GSK Investigational Site
Ilvesheim, Bavaria, 68549
GSK Investigational Site
Kippenheim, Baden-Wurttemberg, 77971
GSK Investigational Site
Künzing, Bavaria, 94550
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67061
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68199
GSK Investigational Site
Munich, Bavaria, 80469
GSK Investigational Site
Munich, Bavaria, 81373
GSK Investigational Site
Munich, Bavaria, 81549
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41466
GSK Investigational Site
Pirna, Saxony, 01796
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624
GSK Investigational Site
Saarlouis, Saarland, 66740
GSK Investigational Site
Schleiz, Thuringia, 07907
GSK Investigational Site
Schlüchtern, Hesse, 36381
GSK Investigational Site
Schwedt, Brandenburg, 16303
GSK Investigational Site
Simmern, Rhineland-Palatinate, 55469
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889
GSK Investigational Site
Speyer, Rhineland-Palatinate, 67346
GSK Investigational Site
Stockach, Baden-Wurttemberg, 78333
GSK Investigational Site
Vellmar, Hesse, 34246
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41751
GSK Investigational Site
Wallerfing, Bavaria, 94574
France19 sites
GSK Investigational Site
Angers, 49000
GSK Investigational Site
Bondy, 93143
GSK Investigational Site
Cholet, 49300
GSK Investigational Site
Corbeil-Essonnes, 91106
GSK Investigational Site
Douai, 59507
GSK Investigational Site
Épinay-sur-Orge, 91360
GSK Investigational Site
La Rochelle, 17019
GSK Investigational Site
Lorient, 56322
GSK Investigational Site
Lyon, 69394
GSK Investigational Site
Montbrison, 42600
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Reims, 51092
GSK Investigational Site
Rennes, 35203
GSK Investigational Site
Roubaix, Hauts-de-France, 59100
GSK Investigational Site
St-Malo, 35403
GSK Investigational Site
Toul, 54201
GSK Investigational Site
Vénissieux, 69200
Spain15 sites
GSK Investigational Site
Alcobendas/Madrid, 28100
GSK Investigational Site
Alicante
GSK Investigational Site
Barcelona, 08022
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Cadiz, 11009
GSK Investigational Site
Galdakano, 48960
GSK Investigational Site
Granada, 18012
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Pontevedra, 36002
GSK Investigational Site
Sabadell (Barcelona), 08208
GSK Investigational Site
Sant Joan d'Alacant, 3550
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Vigo/Pontevedra, 36200
Italy6 sites
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Parma, Emilia-Romagna, 43100
GSK Investigational Site
Perugia, Umbria, 06126
GSK Investigational Site
Pordenone, Friuli Venezia Giulia, 33170
GSK Investigational Site
Treviso, Veneto, 31100
Austria2 sites
GSK Investigational Site
Vienna, A-1030
GSK Investigational Site
Vienna, A-1060
About this study
Official title: A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy
This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone/metformin
- Keywords
- AVANDAMET insulin type 2 diabetes
- 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.
Rosiglitazone/metforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rosiglitazone/metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: 24 weeks
Secondary outcomes (1)
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2003 (estimated)
- Study startOct 2003
- Primary completionNov 2004
- Study completionNov 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 272 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
- NCT00069836
- Sponsor's protocol ID
- 712753/009
- Status last verified
- Aug 2016
- First submitted
- 1 Oct 2003
- Last updated
- 1 Sep 2016
- 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
Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes. Diabet Med. 2007 Jun;24(6):618-25. doi: 10.1111/j.1464-5491.2007.02141.x. Epub 2007 Apr 2.
PubMed 17403121
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Randomised, Double Blind, Parallel Study to Compare the Change in HbA1c With AVANDAMET® (8.0mg / 2.0g) Plus Insulin to Placebo Plus Insulin, in Subjects With Type 2 Diabetes Starting Insulin Therapy
- ClinicalTrials.gov ID
- NCT00069836
- Acronym / sponsor ID
- 712753/009
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- AVANDAMET insulin type 2 diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 3 Oct 2003 (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 was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.
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/metformin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
- Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.
Key exclusion criteria (2 listed)
- Patients cannot have any form of congestive heart failure or severe or unstable angina.
- Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.
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/metformin | Drug | Arm 1 |
Primary outcome
Change from baseline in HbA1c
Time frame: 24 weeks
1 secondary outcome
Insulin dose, FPG,glycaemic responders, beta-cell function, hypoglycaemia, treatment satisfaction
Time frame: 24 weeks
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 1 Sep 2016.
- Results publication: PubMed 17403121Home PD, Bailey CJ, Donaldson J, Chen H, Stewart MW. A double-blind randomized study comparing the effects of continuing or not continuing rosiglitazone + metformin therapy when starting insulin therapy in people with Type 2 diabetes. Diabet Med. 2007 Jun;24(6):618-25. doi: 10.1111/j.1464-5491.2007.02141.x. Epub 2007 Apr 2.
- 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
93 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosiglitazone/metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 93 sites in 5 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 2 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in Germany, France, Spain, Italy, Austria. 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?
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?
Change from baseline in HbA1c (time frame: 24 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 NCT00069836, 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 1 Sep 2016.