Type 2 DiabetesPhase 4GALATEENCT00653302
Phenotype Evaluation in Insulin Naive Patients Using Lantus (Insulin Glargine)
A Phase 4 study testing Lantus (insulin glargine) + Glucophage (Metformin) in people with Type 2 Diabetes, run by Sanofi at 1 site in France.
Trial summary
Primary objective: Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal). Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Lantus (insulin glargine) + Glucophage (Metformin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2003to Oct 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known type 2 diabetes for at least 2 years
- No history of Ketoacidosis
- BMI> 25 \& <35 kg/m2
- Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
- With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
- and metformin at minimal posology 1700mg/day (1320 mg of metformin),
- HbA1c >= 7.5 and <11% for 2 different dosages during the last year
Who cannot join
- Type 1 diabetes
- Glucophage intolerability
- Pregnancy
- Breast feeding
- Partial pancreatectomy
- Hypersensitivity to insulin glargine excipient
Show all 11Show fewer
- Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient
- Hepatitis with transaminases >3ULN
- Pre-proliferative or proliferative retinopathy
- Acute cardiovascular accident within the last 6 months
- Previous treatment with insulin within the last 6 months before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment
Primary objective:
- Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Read more
Secondary objectives:
- Determination of the predictive criterion of HbA1c final,
- Determination of the predictive criterion of weight variation,
- Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
- Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).
Safety:
- Adverse Event (AE)/Serious Adverse Event (SAE) assessments
- Conditions
- Type 2 Diabetes
- Being tested
- Lantus (insulin glargine) + Glucophage (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.
Lantus (insulin glargine) + Glucophage (Metformin)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lantus once a day plus Glucophage 1000mg, twice a day per os Receives: Drug: Lantus (insulin glargine) + Glucophage (Metformin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Measured: During the study conduct
Secondary outcomes (4)
Determination of the predictive criterion of HbA1c final
Measured: During the study conduct
Determination of the predictive criterion of weight variation
Measured: During all the study conduct
HbA1c and weight variations (final value - basal value)
Measured: during the study
AE/SAE evaluation
Measured: from the informed consent signed up 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 posted4 Apr 2008 (estimated)
- Study startApr 2003
- Primary completionSep 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathalie Billon, Study director, Sanofi-aventis administrative office France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653302
- Sponsor's protocol ID
- HOE901_4043
- Acronym
- GALATEE
- Status last verified
- Dec 2008
- First submitted
- 1 Apr 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment
- ClinicalTrials.gov ID
- NCT00653302
- Acronym / sponsor ID
- GALATEE / HOE901_4043
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 4 Apr 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.
Primary objective:
- Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Secondary objectives:
- Determination of the predictive criterion of HbA1c final,
- Determination of the predictive criterion of weight variation,
- Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
- Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).
Safety:
- Adverse Event (AE)/Serious Adverse Event (SAE) assessments
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: Lantus (insulin glargine) + Glucophage (Metformin)Lantus once a day plus Glucophage 1000mg, twice a day per os |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Known type 2 diabetes for at least 2 years
- No history of Ketoacidosis
- BMI> 25 \& <35 kg/m2
- Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
- HbA1c >= 7.5 and <11% for 2 different dosages during the last year
Key exclusion criteria (11 listed)
- Type 1 diabetes
- Glucophage intolerability
- Pregnancy
- Breast feeding
- Partial pancreatectomy
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) + Glucophage (Metformin) | Drug | 1 |
Primary outcome
% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Time frame: During the study conduct
4 secondary outcomes
Determination of the predictive criterion of HbA1c final
Time frame: During the study conduct
Determination of the predictive criterion of weight variation
Time frame: During all the study conduct
HbA1c and weight variations (final value - basal value)
Time frame: during the study
AE/SAE evaluation
Time frame: from the informed consent signed up 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 3 Dec 2008.
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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.
Nathalie Billon study director
Sanofi-aventis administrative office France
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 (insulin glargine) + Glucophage (Metformin) in people with Type 2 Diabetes, run by Sanofi at 1 site in France.
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 11 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 3 Dec 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 France. 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?
% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal). (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?
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 3 Dec 2008.