Diabetes Mellitus Type 2Phase 3NCT00744926
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
A Phase 3 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 58 sites in 11 countries.
Trial summary
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 373 participants
- Where
- 58 sitesin 11 countries
- Study dates
- Aug 2008to Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-80 years of age;
- drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
- C-peptide (fasting) >=1.0ng/mL
- HbA1c >=6.5% and <=10.0% at screening;
- BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Who cannot join
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- symptomatic poorly controlled diabetes;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
Trial locations and contacts
58 sites in 11 countries.
58 sites in 11 countries
United States10 sites
Study site
Avon, Indiana, 46123
Study site
Charlotte, North Carolina, 28211
Study site
Greer, South Carolina, 29651
Study site
Los Angeles, California, 90057
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Pahrump, Nevada, 89048
Study site
Phoenix, Arizona, 85015
Study site
Richmond, Virginia, 23294
Study site
San Antonio, Texas, 78237
Study site
Santa Ana, California, 92701
Russia10 sites
Study site
Chelyabinsk, 454136
Study site
Jaloslave
Study site
Moscow, 109263
Study site
Moscow, 117036
Study site
Moscow, 119048
Study site
Moscow, 129110
Study site
S. Petersburg, 195067
Study site
S.petersburg, 194017
Study site
Saint Petersburg, 191124
Study site
Yaroslavl, 150062
Israel7 sites
Study site
Haifa, 31096
Study site
Haifa, 34162
Study site
Holon, 58100
Study site
Jerusalem, 91200
Study site
Kfar Saba, 44281
Study site
Petah Tikva, 49100
Study site
Tel Aviv, 64239
Mexico6 sites
Study site
Acapulco, 39670
Study site
Aguascalientes, 20230
Study site
Chihuahua City, 31238
Study site
Hermosillo, 83200
Study site
Mexico City, 11650
Study site
Morelia, 58000
Romania6 sites
Study site
Bucharest, 020359
Study site
Buzău, 120203
Study site
Cluj-Napoca, 400006
Study site
Ploieşti, 100163
Study site
Ploieşti, 100342
Study site
Tg. Mures, 540142
Slovakia5 sites
Study site
Dolný Kubín, 02601
Study site
Levice, 034 01
Study site
Prešov, 080 01
Study site
Trenčín, 911 01
Study site
Žilina, 010 01
Taiwan4 sites
Study site
Changhua, 500
Study site
Tainan, 710
Study site
Taipei, 100
Study site
Tapei County, 231
Ukraine4 sites
Study site
Chernivtsi, 58002
Study site
Kiev, 01601
Study site
Kiev, 04050
Study site
Lviv, 79010
Guatemala2 sites
Study site
Guatemala City, 01010
Study site
Guatemala City, 01014
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, 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
taspoglutideDrug
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| taspoglutide 10mg sc | Experimental | Not described Receives: Drug: taspoglutide |
| taspoglutide 10mg/20mg sc | 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)
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Measured: Throughout study
Change from baseline in fasting plasma glucose; change from baseline in body weight.
Measured: 24 weeks
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
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 posted1 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2010
- Study completionApr 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
- 373 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
- NCT00744926
- Sponsor's protocol ID
- BC20750
- Other IDs
- 2008-001765-28, 2008
- Status last verified
- Jul 2016
- First submitted
- 29 Aug 2008
- 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 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
- ClinicalTrials.gov ID
- NCT00744926
- Acronym / sponsor ID
- BC20750
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Sep 2008 (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 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, 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
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| taspoglutide 10mg sc | Experimental | Drug: taspoglutide |
| taspoglutide 10mg/20mg sc | Experimental | Drug: taspoglutide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult patients, 18-80 years of age;
- drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
- C-peptide (fasting) >=1.0ng/mL
- HbA1c >=6.5% and <=10.0% at screening;
Key exclusion criteria (5 listed)
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- symptomatic poorly controlled diabetes;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
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 | Drug | taspoglutide 10mg sc |
| taspoglutide20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) | Drug | taspoglutide 10mg/20mg sc |
Primary outcome
Absolute change from baseline in HbA1c
Time frame: 24 weeks
3 secondary outcomes
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Time frame: Throughout study
Change from baseline in fasting plasma glucose; change from baseline in body weight.
Time frame: 24 weeks
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
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 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
58 sites in 11 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 58 sites in 11 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 7 inclusion and 5 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 58 sites in United States, Russia, Israel, Mexico, Romania and 6 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.