Diabetes Mellitus Type 2Phase 2NCT00111631
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
A Phase 2 study testing DPP-IV Inhibitor and Metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 37 sites in 6 countries.
Trial summary
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. 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?
- DPP-IV Inhibitor and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 37 sitesin 6 countries
- Study dates
- May 2005to Oct 2006
- 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;
- stable metformin therapy for >=3 months before screening.
Who cannot join
- women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin in the last 3 months.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United States20 sites
Study site
Boulder, Colorado, 80304
Study site
Buffalo, New York, 14209
Study site
Chicago, Illinois, 60607
Study site
Clearwater, Florida, 33765
Study site
Concord, California, 94520
Study site
Connellsville, Pennsylvania, 15425
Study site
Dallas, Texas, 75246
Study site
Detroit, Michigan, 48202-2689
Study site
Durham, North Carolina, 27713
Study site
Miami, Florida, 33156
Study site
Midland, Texas, 79707
Study site
Mogadore, Ohio, 44260
Study site
Newark, Delaware, 19713
Study site
Portland, Oregon, 97239
Study site
Rochester, New York, 14609
Study site
Salinas, California, 93901
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92161
Study site
Warminster, Pennsylvania, 18974
Study site
Wilmington, Delaware, 19085
Germany6 sites
Study site
Bad Lauterberg im Harz, 37431
Study site
Berlin, 10115
Study site
Dresden, 01307
Study site
Görlitz, 02826
Study site
Mainz, 55116
Study site
Neuss, 41460
Canada4 sites
Study site
Halifax, Nova Scotia, B3H 1V7
Study site
London, Ontario, NGA 4V2
Study site
Toronto, Ontario, M5C 2T2
Study site
Winnipeg, Manitoba, R3E 3P4
Italy4 sites
Study site
Ancona, 60131
Study site
Florence, 50100
Study site
Naples, 80100
Study site
Udine, 33100
About this study
Official title: A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin
This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- DPP-IV Inhibitor, Metformin, Placebo
- 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.
DPP-IV InhibitorDrug
Escalating doses po bid
MetforminDrug
As prescribed
PlaceboDrug
po bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DPP-IV Inhibitor; Drug: Metformin |
| 2 | Experimental | Not described Receives: Drug: DPP-IV Inhibitor; Drug: Metformin |
| 3 | Experimental | Not described Receives: Drug: DPP-IV Inhibitor; Drug: Metformin |
| 4 | Placebo comparator | Not described Receives: Drug: Metformin; 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\n
Measured: Week 16
Secondary outcomes (2)
Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
Measured: Week 16
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
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 posted25 May 2005 (estimated)
- Study startMay 2005
- Primary completionOct 2006
- Study completionOct 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 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
- NCT00111631
- Sponsor's protocol ID
- BM18106
- Status last verified
- Nov 2016
- First submitted
- 24 May 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
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 Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin
- ClinicalTrials.gov ID
- NCT00111631
- Acronym / sponsor ID
- BM18106
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 25 May 2005 (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 will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 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
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DPP-IV Inhibitor, Drug: Metformin |
| 2 | Experimental | Drug: DPP-IV Inhibitor, Drug: Metformin |
| 3 | Experimental | Drug: DPP-IV Inhibitor, Drug: Metformin |
| 4 | Placebo comparator | Drug: Metformin, 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;
- stable metformin therapy for >=3 months before screening.
Key exclusion criteria (3 listed)
- women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
- type 1 diabetes;
- any anti-hyperglycemic medication other than metformin in the last 3 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 |
|---|---|---|
| DPP-IV InhibitorEscalating doses po bid | Drug | 1, 2, 3 |
| MetforminAs prescribed | Drug | 1, 2, 3, 4 |
| Placebopo bid | Drug | 4 |
Primary outcome
Absolute change from baseline in HbAlc\n
Time frame: Week 16
2 secondary outcomes
Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n
Time frame: Week 16
AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n
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.
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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
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DPP-IV Inhibitor and Metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 37 sites in 6 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 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 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 37 sites in United States, Germany, Canada, Italy, Australia and 1 more country. 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\n (time frame: Week 16). 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 2 Nov 2016.