Diabetes Mellitus, Type 1Phase 4GLANSNCT00539448
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study
A Phase 4 study testing insulin glargine and insulin glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 4 sites in 4 countries.
Trial summary
Primary objective : To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin glargine and insulin glulisine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Apr 2007to Dec 2008
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed type I diabetic patients
- Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
- BMI, 26-40 kg/m2
- HbA1c, 7.5%-10%
- Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
- FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
- Willingness to accept, and ability to inject insulin Glargine therapy
Who cannot join
- Pregnancy : The use of LANTUS \& APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population
- 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
4 sites in 4 countries.
4 sites in 4 countries
United Arab Emirates1 site
Sanofi-aventis administrative office
Dubai
About this study
Official title: Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.
Primary objective :
To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.
Secondary objective :
- Recording the average daily dose of both insulin Glulisine \& insulin Glargine in type I DM.
- Recording adverse events.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- insulin glargine, insulin glulisine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargineDrug
in combination with insulin Glulisine as bolus regimen
insulin glulisineDrug
in combination with insulin Glargine as bolus regimen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | combination of insulin Glargine \& insulin Glulisine as basal bolus regimen Receives: Drug: insulin glargine; Drug: insulin glulisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the Glycemic control of the regimen : Change in A1C levels
Measured: from baseline to study end
Secondary outcomes (1)
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?
Measured: from baseline to study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hisham - MAHMOUD, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539448
- Sponsor's protocol ID
- LANTU_L_01578
- Acronym
- GLANS
- Status last verified
- Sep 2009
- First submitted
- 3 Oct 2007
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open Label, Non-comparative, Multi-center, Study of the Effects of Both Insulin Glargine & Insulin Glulisine in Type I Diabetes Mellitus Patients.
- ClinicalTrials.gov ID
- NCT00539448
- Acronym / sponsor ID
- GLANS / LANTU_L_01578
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Oct 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.
Primary objective :
To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks \& at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.
Secondary objective :
- Recording the average daily dose of both insulin Glulisine \& insulin Glargine in type I DM.
- Recording adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: insulin glargine, Drug: insulin glulisinecombination of insulin Glargine \& insulin Glulisine as basal bolus regimen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Newly diagnosed type I diabetic patients
- Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
- BMI, 26-40 kg/m2
- HbA1c, 7.5%-10%
- Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
Key exclusion criteria (2 listed)
- Pregnancy : The use of LANTUS \& APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population
- 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 |
|---|---|---|
| insulin glarginein combination with insulin Glulisine as bolus regimen | Drug | 1 |
| insulin glulisinein combination with insulin Glargine as bolus regimen | Drug | 1 |
Primary outcome
Evaluating the Glycemic control of the regimen : Change in A1C levels
Time frame: from baseline to study end
1 secondary outcome
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?
Time frame: from baseline to study end
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 Sep 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.
Hisham - MAHMOUD, MD study director
Sanofi
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin glargine and insulin glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 4 sites in 4 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 7 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 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bahrain, Kuwait, Qatar, United Arab Emirates. 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?
Evaluating the Glycemic control of the regimen : Change in A1C levels (time frame: from baseline to study end). 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 25 Sep 2009.