Diabetes MellitusPhase 3NCT00046462
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
A Phase 3 study testing Lantus (insulin glargine [rDNA origin] injection), Metformin and Glyburide in people with Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Lantus (insulin glargine [rDNA origin] injection), Metformin and Glyburide
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2004
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 - 79 years of age
- With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months
Who cannot join
- Major cardiovascular events
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
- Conditions
- Diabetes Mellitus
- Being tested
- Lantus (insulin glargine [rDNA origin] injection), Metformin, Glyburide, Thiazolidinedione
- 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 (insulin glargine [rDNA origin] injection)Drug
MetforminDrug
GlyburideDrug
ThiazolidinedioneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
Measured: During the Study Conduct
Secondary outcomes (6)
Occurrence of hypoglycemia
Measured: During the study conduct
Change in fasting plasma glucose
Measured: During the study conduct
Percentage of patients achieving HbA1C less than or equal to 7%
Measured: During the study conduct
Time to glycemic control
Measured: During the study conduct
Change in body weight
Measured: During the study conduct
Change in serum lipid profile
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2002 (estimated)
- Study startNov 2001
- Primary completionNov 2004
- Study completionDec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doug Green, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046462
- Sponsor's protocol ID
- HOE901_4022
- Status last verified
- Jan 2011
- First submitted
- 30 Sep 2002
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5.
PubMed 26281972
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination
- ClinicalTrials.gov ID
- NCT00046462
- Acronym / sponsor ID
- HOE901_4022
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 2 Oct 2002 (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.
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 - 79 years of age
- With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months
Key exclusion criteria (2 listed)
- Major cardiovascular events
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 (insulin glargine [rDNA origin] injection) | Drug | – |
| Metformin | Drug | – |
| Glyburide | Drug | – |
| Thiazolidinedione | Drug | – |
Primary outcome
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
Time frame: During the Study Conduct
6 secondary outcomes
Occurrence of hypoglycemia
Time frame: During the study conduct
Change in fasting plasma glucose
Time frame: During the study conduct
Percentage of patients achieving HbA1C less than or equal to 7%
Time frame: During the study conduct
Time to glycemic control
Time frame: During the study conduct
Change in body weight
Time frame: During the study conduct
Change in serum lipid profile
Time frame: During the study conduct
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 11 Jan 2011.
- Derived from this study: PubMed 26281972Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5.
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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.
Doug Green 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 3 study testing Lantus (insulin glargine [rDNA origin] injection), Metformin and Glyburide in people with Diabetes Mellitus, run by Sanofi at 1 site in United States.
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 2 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 11 Jan 2011. 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 United States. 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 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?
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy (time frame: During the Study Conduct). 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 NCT00046462, 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 11 Jan 2011.