Diabetes Mellitus Type 2Phase 3NCT00823992
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
A Phase 3 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 71 sites in 10 countries.
Trial summary
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- taspoglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 71 sitesin 10 countries
- Study dates
- Jan 2009to May 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
- HbA1c >=6.5% and <=9.5% at screening;
- BMI >=30 and <=50 kg/m2 at screening;
- stable weight +/-5% for at least 12 weeks prior to screening.
Who cannot join
- history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
- evidence of clinically significant diabetic complications;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Trial locations and contacts
71 sites in 10 countries.
71 sites in 10 countries
United States29 sites
Study site
Albuquerque, New Mexico, 87131
Study site
Atlanta, Georgia, 30342
Study site
Avon, Indiana, 46123
Study site
Bangor, Maine, 04401
Study site
Bermuda Dunes, California, 92203
Study site
Brooksville, Florida, 34601
Study site
Charlotte, North Carolina, 28277
Study site
Chicago, Illinois, 60607
Study site
Clifton, New Jersey, 07012
Study site
Clinton, South Carolina, 29325
Study site
Dallas, Texas, 75246
Study site
Houston, Texas, 77074
Study site
Kingsport, Tennessee, 37660
Study site
La Jolla, California, 92037
Study site
Los Angeles, California, 90057
Study site
Medford, Oregon, 97504
Study site
Miami, Florida, 33133
Study site
Midland, Texas, 79707
Study site
Mission Viejo, California, 92691
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10025
Study site
Norman, Oklahoma, 73069
Study site
Picayune, Mississippi, 39466
Study site
Royal Oak, Michigan, 48073
Study site
San Antonio, Texas, 78237
Study site
Shelby, North Carolina, 28150
Study site
Springfield Gardens, New York, 11413
Study site
St. Petersburg, Florida, 33709
Study site
Toms River, New Jersey, 08753
Germany9 sites
Study site
Aschaffenburg, 63739
Study site
Berlin, 10115
Study site
Bochum, 44791
Study site
Dortmund, 44137
Study site
Dresden, 01307
Study site
Falkensee, 14612
Study site
Mainz, 55116
Study site
Münster, 48145
Study site
Neuwied, 56564
Russia8 sites
Study site
Kemerovo, 650002
Study site
Moscow, 105229
Study site
Moscow, 115280
Study site
Moscow, 117036
Study site
Ryazan, 390026
Study site
Saratov, 410002
Study site
Smolensk, 214019
Study site
Tyumen, 625023
Canada6 sites
Study site
Etobicoke, Ontario, M9R 4E1
Study site
Hamilton, Ontario, L8N 3Z5
Study site
Oakville, Ontario, L6H 3P1
Study site
Sherbrooke, Nova Scotia, J1G 2E8
Study site
Toronto, Ontario, M9W 4L6
Study site
Vancouver, British Columbia, V5Z 1L8
United Kingdom5 sites
Study site
Bath, BA2 4BY
Study site
Birmingham, B9 5SS
Study site
Glasgow, G45 9AW
Study site
Midsomer Norton, BA3 2UH
Study site
Rotherham, S65 1DA
Italy4 sites
Study site
Ancona, 60131
Study site
Ravenna, 48100
Study site
Roma, 00161
Study site
Siena, 53100
Poland3 sites
Study site
Gniewkowo, 88-140
Study site
Kamieniec Ząbkowicki, 57-230
Study site
Lublin, 20-044
Puerto Rico3 sites
Study site
Carolina, 00983
Study site
Rio Grande, 00745
Study site
Rio Piedras, 00921
Spain3 sites
Study site
Barcelona, 08036
Study site
Lleida, 25198
Study site
Oviedo, 33006
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- placebo, taspoglutide
- 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.
placeboDrug
sc once weekly
taspoglutideDrug
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| taspoglutide | Experimental | Not described Receives: Drug: taspoglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in HbA1c
Measured: 24 weeks
Secondary outcomes (3)
Change from baseline in body weight;% of patients achieving >=5% weight loss
Measured: 24 weeks
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Measured: 24 weeks
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
Measured: At planned clinic visits, for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823992
- Sponsor's protocol ID
- BC22092
- Other IDs
- 2008-005809-20, 2008
- Status last verified
- Jul 2016
- First submitted
- 15 Jan 2009
- Last updated
- 28 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
- ClinicalTrials.gov ID
- NCT00823992
- Acronym / sponsor ID
- BC22092
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Jan 2009 (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 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| taspoglutide | Experimental | Drug: taspoglutide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
- HbA1c >=6.5% and <=9.5% at screening;
- BMI >=30 and <=50 kg/m2 at screening;
- stable weight +/-5% for at least 12 weeks prior to screening.
Key exclusion criteria (3 listed)
- history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
- evidence of clinically significant diabetic complications;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
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 |
|---|---|---|
| placebosc once weekly | Drug | placebo |
| taspoglutide10mg sc once weekly for 4 weeks, then 20mg sc once weekly | Drug | taspoglutide |
Primary outcome
Absolute change from baseline in HbA1c
Time frame: 24 weeks
3 secondary outcomes
Change from baseline in body weight;% of patients achieving >=5% weight loss
Time frame: 24 weeks
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Time frame: 24 weeks
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
Time frame: At planned clinic visits, for 12 months
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 28 Jul 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
71 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 71 sites in 10 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 5 inclusion and 3 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 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Germany, Russia, Canada, United Kingdom and 5 more countries. 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. Some participants in this study may receive a placebo. 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?
Absolute 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?
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 28 Jul 2016.