Diabetes MellitusPhase 4NCT00642915
Insulin Glargine Benefits in Japanese Pts Outside of Japan (US or Brazil)
A Phase 4 study testing Lantus, Amaryl in people with Diabetes Mellitus, run by Sanofi at 1 site in Brazil.
Trial summary
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Lantus, Amaryl
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2003to Jul 2004
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
- Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
- Conditions
- Diabetes Mellitus
- Being tested
- Lantus, Amaryl
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lantus, AmarylDrug
Also called insulin glargine,glimepiride
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy
Measured: Hemoglobin A1c values were measured at Screening and at every visit thereafter.
Secondary outcomes (1)
Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
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 posted25 Mar 2008 (estimated)
- Study startJun 2003
- Study completionJul 2004
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 MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tadaaki Karino, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642915
- Sponsor's protocol ID
- HOE901_4039
- Status last verified
- Aug 2008
- First submitted
- 19 Mar 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
Publications
Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4.
PubMed 17919763
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs)
- ClinicalTrials.gov ID
- NCT00642915
- Acronym / sponsor ID
- HOE901_4039
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 25 Mar 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.
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients planned for enrollment into this study had to have noninsulin-dependent diabetes mellitus (NIDDM) (type 2 diabetes) and were not able to maintain good metabolic control with OADs.
- Enrolled patients could be male or female, of documented Japanese ethnic origin, and between the ages of 20 and 70 years, inclusive.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lantus, AmarylAlso: insulin glargine,glimepiride | Drug | – |
Primary outcome
Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy
Time frame: Hemoglobin A1c values were measured at Screening and at every visit thereafter.
1 secondary outcome
Document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
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 25 Aug 2008.
- Background: PubMed 17919763Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008 Jan;79(1):97-102. doi: 10.1016/j.diabres.2007.08.007. Epub 2007 Oct 4.
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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.
Tadaaki Karino study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lantus, Amaryl in people with Diabetes Mellitus, run by Sanofi at 1 site in Brazil.
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 2 inclusion and 0 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 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Estimate the efficacy of combination therapy with Lantus plus Amarylin controlling blood glucose in Japanese patients with type 2 diabetes having failed oral antidiabetic drug therapy (time frame: Hemoglobin A1c values were measured at Screening and at every visit thereafter.). 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 NCT00642915, 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 25 Aug 2008.