Type 2 Diabetes MellitusPhase 4NCT00358124
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
A Phase 4 study testing insulin glargine, rosiglitazone and metformin in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- insulin glargine, rosiglitazone and metformin
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jun 2002
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus for at least one year;
- Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
- Glycated hemoglobin between 7.5 and 11 % units, inclusive;
- Willingness to accept, and ability to inject insulin glargine therapy
Who cannot join
- Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
- Congestive heart failure requiring pharmacological treatment;
- Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- Planned radiological examinations requiring administration of contrasting agents;
- Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
Show all 15Show fewer
- History of hypoglycemia unawareness;
- Pregnancy or lactation;
- Failure to use adequate contraception (women of current reproductive potential only);
- Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
- BMI >25 kg/m2;
- Malignancy except basal cell carcinoma within the last five years;
- History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
- Incapability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- insulin glargine, rosiglitazone, metformin
- 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.
insulin glargineDrug
rosiglitazoneDrug
metforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
Secondary outcomes (5)
Secondary efficacy parameters were: a mean change from baseline in FPG
Mean change from baseline in fasting insulin/C-peptide levels
Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
Mean change from baseline for bodyweight.
Health-related quality of life was compared between the baseline visit and the follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study startJan 2001
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Barch, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358124
- Sponsor's protocol ID
- HOE901_4014
- Status last verified
- Jan 2011
- First submitted
- 28 Jul 2006
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care. 2006 Mar;29(3):554-9. doi: 10.2337/diacare.29.03.06.dc05-0695.
PubMed 16505505Vinik AI, Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007 Apr;30(4):795-800. doi: 10.2337/dc06-1712. Epub 2007 Jan 26.
PubMed 17259481
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
- Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
- ClinicalTrials.gov ID
- NCT00358124
- Acronym / sponsor ID
- HOE901_4014
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Jun 2002
- First posted
- 31 Jul 2006 (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 compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes mellitus for at least one year;
- Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
- Glycated hemoglobin between 7.5 and 11 % units, inclusive;
- Willingness to accept, and ability to inject insulin glargine therapy
Key exclusion criteria (15 listed)
- Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
- Congestive heart failure requiring pharmacological treatment;
- Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- Planned radiological examinations requiring administration of contrasting agents;
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 |
|---|---|---|
| insulin glargine | Drug | – |
| rosiglitazone | Drug | – |
| metformin | Drug | – |
Primary outcome
The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
5 secondary outcomes
Secondary efficacy parameters were: a mean change from baseline in FPG
Mean change from baseline in fasting insulin/C-peptide levels
Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
Mean change from baseline for bodyweight.
Health-related quality of life was compared between the baseline visit and the follow-up assessments
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.
- Background: PubMed 16505505Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care. 2006 Mar;29(3):554-9. doi: 10.2337/diacare.29.03.06.dc05-0695.
- Background: PubMed 17259481Vinik AI, Zhang Q. Adding insulin glargine versus rosiglitazone: health-related quality-of-life impact in type 2 diabetes. Diabetes Care. 2007 Apr;30(4):795-800. doi: 10.2337/dc06-1712. Epub 2007 Jan 26.
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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.
Karen Barch 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 insulin glargine, rosiglitazone and metformin in people with Type 2 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 4 inclusion and 15 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 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?
The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.. The study lists 2 primary outcomes in all. 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 NCT00358124, which also lists 2 linked publications.
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.