Diabetes Mellitus, Type 2Phase 4NCT00258804
Insulin Glargine During and After the Period of Fasting in Ramadan
A Phase 4 study testing Insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.
Trial summary
Primary Objectives : To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin glargine
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Feb 2006
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
- BMI > 25 and < 40 kg/m2;
- Willingness to participate and to fast during Ramadan;
- Patients should be either:
- Insulin naïve patients
- Patients already receiving insulin
Who cannot join
- Pregnancy (as determined by pregnancy blood test at inclusion visit)
- Breast- feeding
- Women of childbearing potential who do not have adequate contraceptive protection
- Need for treatment during the study period with medications that may interfere with the study protocol
- Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
- History of drug or alcohol abuse
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- Severe and unbalanced diabetic retinopathy
- Clinically relevant cardiovascular, gastrointestinal, hepatic, renal, neurological, endocrine, hematological or other major systemic diseases that may interfere with the study protocol or complicate the interpretation of study results
- Night shift workers
About this study
Official title: Evaluation (Safety and Efficacy) of Treatment With Insulin Glargine and Glimepiride in Patients With Type 2 Diabetes Before, During and After the Period of Fasting in Ramadan
Primary Objectives :
- To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.
Read more
Secondary Objectives :
- To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary).
- To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan.
- To assess patient satisfaction
- To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin glargine
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
All other adverse events before, during and after Ramadan
Patient satisfaction before, during and after Ramadan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick SINNASSAMY, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258804
- Sponsor's protocol ID
- HOE901_4055
- Status last verified
- Jun 2011
- First submitted
- 24 Nov 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation (Safety and Efficacy) of Treatment With Insulin Glargine and Glimepiride in Patients With Type 2 Diabetes Before, During and After the Period of Fasting in Ramadan
- ClinicalTrials.gov ID
- NCT00258804
- Acronym / sponsor ID
- HOE901_4055
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 28 Nov 2005 (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 Objectives :
- To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.
Secondary Objectives :
- To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary).
- To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan.
- To assess patient satisfaction
- To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Type 2 Diabetes mellitus (but without history of ketoacidosis);
- BMI > 25 and < 40 kg/m2;
- Willingness to participate and to fast during Ramadan;
- Patients should be either:
Key exclusion criteria (9 listed)
- Pregnancy (as determined by pregnancy blood test at inclusion visit)
- Breast- feeding
- Women of childbearing potential who do not have adequate contraceptive protection
- Need for treatment during the study period with medications that may interfere with the study protocol
- Treatment with any investigational drug (only if in trial) in the last 3 months before entry into the study
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 | – |
Primary outcome
Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan
Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile
All other adverse events before, during and after Ramadan
Patient satisfaction before, during and after Ramadan.
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 8 Jun 2011.
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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.
Patrick SINNASSAMY, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin glargine 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 6 inclusion and 9 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 8 Jun 2011. 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?
Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan. The study lists 4 primary outcomes in all. 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 8 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.