Diabetes Mellitus Type 2Phase 2NCT00423501
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
A Phase 2 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 49 sites in 10 countries.
Trial summary
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 49 sitesin 10 countries
- Study dates
- Feb 2007to Nov 2007
- 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
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- stable weight +/-10% for >=3 months before screening.
Who cannot join
- type 1 diabetes mellitus;
- 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.
Trial locations and contacts
49 sites in 10 countries.
49 sites in 10 countries
United States10 sites
Study site
Chicago, Illinois, 60607
Study site
Dallas, Texas, 75246
Study site
Midland, Texas, 79707
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 23249
Study site
Rochester, New York, 14609
Study site
San Antonio, Texas, 78229
Study site
Springfield, Illinois, 62704-1433
Study site
Washington D.C., District of Columbia, 20010
Study site
Woodstock, Georgia, 30189
Romania10 sites
Study site
Brasov, 500365
Study site
Bucharest, 020475
Study site
Bucharest, 050452
Study site
Bucharest
Study site
Cluj-Napoca, 400006
Study site
Jud Covasna, 520064
Study site
Mures, 540011
Study site
Ploieşti, 100163
Study site
Satu Mare, 3900
Study site
Sibiu, 550245
Mexico8 sites
Study site
Guadalajara, 44340
Study site
Guadalajara, 44650
Study site
Mexico City, 03100
Study site
Mexico City, 11650
Study site
Mexico City, 14080
Study site
Mexico City, 14610
Study site
Monterrey, 64460
Study site
Pachuca, 42086
Germany7 sites
Study site
Bad Lauterberg im Harz, 37431
Study site
Berlin, 10115
Study site
Görlitz, 02826
Study site
Hanover, 30167
Study site
Mainz, 55116
Study site
Neuss, 41460
Study site
Nuremberg, 90402
Bulgaria6 sites
Study site
Dimitrovgrad, 6400
Study site
Pleven, 5800
Study site
Rousse, 7002
Study site
Sofia, 1233
Study site
Sofia, 1606
Study site
Varna, 9010
Lithuania3 sites
Study site
Kaunas, 51270
Study site
Klaipėda, 92304
Study site
Vilnius, 08661
About this study
Official title: A Double Blind, Placebo-controlled, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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
- 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
taspoglutideDrug
20mg sc weekly
taspoglutideDrug
10mg sc every 2 weeks
taspoglutideDrug
5mg sc weekly
taspoglutideDrug
10mg sc weekly
taspoglutideDrug
20mg sc every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: taspoglutide |
| 2 | Experimental | Not described Receives: Drug: taspoglutide |
| 3 | Experimental | Not described Receives: Drug: taspoglutide |
| 4 | Experimental | Not described Receives: Drug: taspoglutide |
| 5 | Experimental | Not described Receives: Drug: taspoglutide |
| 6 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in HbAlc
Measured: Week 8
Secondary outcomes (3)
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Measured: Week 8
Changes in lipid profile
Measured: Week 8
AEs, laboratory parameters, primary pharmacokinetic parameters
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
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
- 306 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
- NCT00423501
- Sponsor's protocol ID
- BC20688
- Status last verified
- Nov 2016
- First submitted
- 17 Jan 2007
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.
PubMed 19366970
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, Dose-ranging Study to Investigate the Effect on Glycemic Control, Safety, Pharmacokinetics and Pharmacodynamics of GLP-1 in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.
- ClinicalTrials.gov ID
- NCT00423501
- Acronym / sponsor ID
- BC20688
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jan 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 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens 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, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. 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
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: taspoglutide |
| 2 | Experimental | Drug: taspoglutide |
| 3 | Experimental | Drug: taspoglutide |
| 4 | Experimental | Drug: taspoglutide |
| 5 | Experimental | Drug: taspoglutide |
| 6 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus, with stable metformin treatment for >=3 months;
- stable weight +/-10% for >=3 months before screening.
Key exclusion criteria (4 listed)
- type 1 diabetes mellitus;
- 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 | 6 |
| taspoglutide20mg sc weekly | Drug | 3 |
| taspoglutide10mg sc every 2 weeks | Drug | 4 |
| taspoglutide5mg sc weekly | Drug | 1 |
| taspoglutide10mg sc weekly | Drug | 2 |
| taspoglutide20mg sc every 2 weeks | Drug | 5 |
Primary outcome
Absolute change from baseline in HbAlc
Time frame: Week 8
3 secondary outcomes
Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon.
Time frame: Week 8
Changes in lipid profile
Time frame: Week 8
AEs, laboratory parameters, primary pharmacokinetic parameters
Time frame: Throughout study
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 19366970Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14.
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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
49 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 49 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 3 inclusion and 4 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 49 sites in United States, Romania, Mexico, Germany, Bulgaria 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 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?
Absolute change from baseline in HbAlc (time frame: Week 8). 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 NCT00423501, 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.