Diabetes Mellitus, Type 2Phase 4GOTNCT00552370
Glycemic Optimization Treatment Study
A Phase 4 study testing Lantus® in people with Diabetes Mellitus, Type 2, run by Sanofi.
Trial summary
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lantus®
- How many people
- 5,062 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Mar 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must give their signed informed consent.
- Diagnosis of Type 2 DM for at least 6 months.
- Males and females greater than or equal to 18 years of age.
- A1c greater than or equal to 7.0%.
- Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
- Demonstrated willingness and ability to inject insulin glargine.
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- Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
- Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
- BMI greater than 25.0 kg/m2.
- Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.
Who cannot join
- Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
- For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
- For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
- Planned pregnancy, pregnancy, or lactation.
- Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
- Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
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- Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
- Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Hypersensitivity to Lantus® insulin or any of its components.
- Any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study.
- Current (last 2 months) insulin therapy.
- With the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Randomized, Open-Label, Parallel-Design Trial. Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lantus®
- 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.
Lantus®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).
Measured: From the start to the end of the study
Secondary outcomes (1)
To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.
Measured: From the start to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startMar 2003
- Primary completionMar 2005
- Study completionMar 2005
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 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
- 5,062 participants (actual)
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
- NCT00552370
- Sponsor's protocol ID
- HOE901_4045
- Acronym
- GOT
- Status last verified
- Jul 2009
- First submitted
- 31 Oct 2007
- Last updated
- 21 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Design Trial. Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00552370
- Acronym / sponsor ID
- GOT / HOE901_4045
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,062 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 1 Nov 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.
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must give their signed informed consent.
- Diagnosis of Type 2 DM for at least 6 months.
- Males and females greater than or equal to 18 years of age.
- A1c greater than or equal to 7.0%.
- Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
Key exclusion criteria (13 listed)
- Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
- For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
- For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
- Planned pregnancy, pregnancy, or lactation.
- Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
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® | Drug | – |
Primary outcome
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).
Time frame: From the start to the end of the study
1 secondary outcome
To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.
Time frame: From the start to the end of the 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 21 Jul 2009.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lantus® in people with Diabetes Mellitus, Type 2, run by Sanofi.
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 10 inclusion and 13 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 21 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG). (time frame: From the start to the end of the study). 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 21 Jul 2009.