Diabetes Mellitus Type 2Phase 2NCT00460941
A Titration Study of a Glucagon-Like Peptide-1 (GLP-1) Analogue in Patients With Type 2 Diabetes Treated With Metformin.
A Phase 2 study testing Taspoglutide 20mg, Taspoglutide 20mg-30mg and Taspoglutide 20mg-40mg in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 29 sites in 7 countries.
Trial summary
This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. 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 20mg, Taspoglutide 20mg-30mg and Taspoglutide 20mg-40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Apr 2007to Jan 2008
- Phase
- Phase 2
- 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
- male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- HbA1c >=7.0% and <=9.5% at screening;
- stable weight +/-10% for >=3 months before screening.
Who cannot join
- type 1 diabetes mellitus;
- clinically significant gastrointestinal disease;
- treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- use of weight-lowering medications in the last 3 months;
- uncontrolled hypertension;
- previous exposure to GLP-1 or GLP-1 analogues.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
United States11 sites
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75231
Study site
Harrisburg, Arkansas, 72432
Study site
Hot Springs, Arkansas, 71913
Study site
Hyattsville, Maryland, 20783
Study site
Jacksonville, Florida, 32216
Study site
Jonesboro, Arkansas, 72401
Study site
Madisonville, Kentucky, 42431
Study site
National City, California, 91950
Study site
Richmond, Virginia, 23294
Study site
Winston-Salem, North Carolina, 27103
France5 sites
Study site
Besançon, 25030
Study site
Corbeil-Essonnes, 91106
Study site
Narbonne, 11108
Study site
Paris, 75877
Study site
Poitiers, 86021
Mexico4 sites
Study site
Chihuahua City, 31238
Study site
Culiacán, 80020
Study site
Monterrey, 64410
Study site
Tampico, 89109
Germany3 sites
Study site
Berlin, 10115
Study site
München, 80636
Study site
Neuss, 41460
About this study
Official title: A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Placebo, Taspoglutide 20mg, Taspoglutide 20mg-30mg, Taspoglutide 20mg-40mg
- 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 weekly
Taspoglutide 20mgDrug
sc weekly
Taspoglutide 20mg-30mgDrug
sc weekly
Taspoglutide 20mg-40mgDrug
sc weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | sc weekly Receives: Drug: Placebo |
| Taspoglutide 20mg | Experimental | sc weekly Receives: Drug: Taspoglutide 20mg |
| Taspoglutide 20mg-30mg | Experimental | sc weekly Receives: Drug: Taspoglutide 20mg-30mg |
| Taspoglutide 20mg-40mg | Experimental | sc weekly Receives: Drug: Taspoglutide 20mg-40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients withdrawn because of gastrointestinal effects
Measured: Week 9
Secondary outcomes (1)
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 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
- NCT00460941
- Sponsor's protocol ID
- BC20728
- Status last verified
- Nov 2016
- First submitted
- 16 Apr 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x.
PubMed 20536952
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Titration Study to Investigate the Tolerability, Safety and Pharmacodynamic Profile of a GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
- ClinicalTrials.gov ID
- NCT00460941
- Acronym / sponsor ID
- BC20728
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 17 Apr 2007 (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 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebosc weekly |
| Taspoglutide 20mg | Experimental | Drug: Taspoglutide 20mgsc weekly |
| Taspoglutide 20mg-30mg | Experimental | Drug: Taspoglutide 20mg-30mgsc weekly |
| Taspoglutide 20mg-40mg | Experimental | Drug: Taspoglutide 20mg-40mgsc weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male,and post-menopausal or surgically sterilized female, patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- HbA1c >=7.0% and <=9.5% at screening;
- stable weight +/-10% for >=3 months before screening.
Key exclusion criteria (6 listed)
- type 1 diabetes mellitus;
- clinically significant gastrointestinal disease;
- treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- use of weight-lowering medications in the last 3 months;
- uncontrolled hypertension;
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 weekly | Drug | Placebo |
| Taspoglutide 20mgsc weekly | Drug | Taspoglutide 20mg |
| Taspoglutide 20mg-30mgsc weekly | Drug | Taspoglutide 20mg-30mg |
| Taspoglutide 20mg-40mgsc weekly | Drug | Taspoglutide 20mg-40mg |
Primary outcome
Percentage of patients withdrawn because of gastrointestinal effects
Time frame: Week 9
1 secondary outcome
Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters.
Time frame: Week 9
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 2 Nov 2016.
- Derived from this study: PubMed 20536952Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x.
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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
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taspoglutide 20mg, Taspoglutide 20mg-30mg and Taspoglutide 20mg-40mg in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 29 sites in 7 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 4 inclusion and 6 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Mexico, Germany, Peru and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients withdrawn because of gastrointestinal effects (time frame: Week 9). 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 NCT00460941, 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 2 Nov 2016.