Diabetes MellitusPhase 4NCT00609895
The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing
A Phase 4 study testing INSULIN GLARGINE in people with Diabetes Mellitus, run by Sanofi at 1 site in Mexico.
Trial summary
To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- INSULIN GLARGINE
- How many people
- 22 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2004to Aug 2004
- 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 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes mellitus diagnosis for at least 1 year Administration of insulin glargine for at least 2 months prior to screening; subjects must be on a stable dose of insulin glargine, + or - 15%, for at least 1 week prior to screening, given once daily at bedtime, and the dose must remain unchanged (+ or - 15%) during the screening period.
- If subjects are taking a short-acting insulin (e.g., regular human insulin, insulin lispro, or insulin aspart) or oral antidiabetic agents (e.g., a sulfonylurea, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, or a metiglinide), the subject must have been receiving these medications for at least 2 months prior to screening.
- For subjects taking an oral antidiabetic agent, the dose must be unchanged for the 2 weeks (4 weeks for a thiazolidinedione) prior to screening and should not be expected to be changed from the screening visit (day 14) through the final visit (day 11). The dose of any short-acting insulin may be changed if medically indicated.
- Males or non-pregnant females between the ages of 6 and 75 years; women must be postmenopausal for more than 2 years, surgically sterile, or agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
- Ability and willingness to perform blood glucose profiles using a plasma glucose meter provided at home over 11 consecutive days.
- HbA1c < than or = to 8.5% at screening.
Who cannot join
- Use of any other intermediate- or long-acting insulin (e.g., NPH, Ultralenter, Lenter) within the last 2 months prior to screening.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., systemic corticosteroids).
- History of hypoglycemia unawareness.
- Pregnancy (as determined by a serum pregnancy test at the screening visit).
- Breast-feeding.
- Treatment with any investigational drug in the 2 months prior to the screening visit.
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- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- History of drug or alcohol abuse.
- Impaired hepatic function, as shown by but not limited to serum glutamic-oxaloacetic transaminase (SGPT, also known as alanine transaminase [ALT]) or serum glutamic-pyruvic transaminase (SGOT, also known as aspartate transaminase [AST]) above 2x the upper limit of normal range (ULN) measured at the screening visit.
- Impaired renal function, as shown by, but not limited to serum creatinine > than or = to 1.5 mg/dL (133 micromol/L) [males] or > than or = to1.4 mg/dL (124 micromol/L) [females] measured at the screening visit. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Subjects who work the night shift.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.
- Conditions
- Diabetes Mellitus
- Being tested
- INSULIN GLARGINE
- Medical subject headings
- Diabetes Mellitus
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.
Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days
Measured: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
Secondary outcomes (5)
Compare % subjects with glucose measurements < or = to 72 mg/dL & < or = to 36 mg/dL at any point of the 8-point glucose profile during 3 consecutive days
Measured: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the mean daily rate of hypoglycemia during 3 consecutive days
Measured: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the changes from baseline in glucose values at each specific measurement time of the 8-point glucose profile during 3 consecutive days
Measured: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the incidence of symptomatic hypoglycemia
Measured: at any time during 3 consecutive days before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations
Measured: at any time during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Judith Diaz, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609895
- Sponsor's protocol ID
- HOE901_4038
- Status last verified
- Mar 2008
- First submitted
- 24 Jan 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing
- ClinicalTrials.gov ID
- NCT00609895
- Acronym / sponsor ID
- HOE901_4038
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Aug 2004 (actual)
- First posted
- 7 Feb 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.
To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 or type 2 diabetes mellitus diagnosis for at least 1 year Administration of insulin glargine for at least 2 months prior to screening; subjects must be on a stable dose of insulin glargine, + or - 15%, for at least 1 week prior to screening, given once daily at bedtime, and the dose must remain unchanged (+ or - 15%) during the screening period.
- If subjects are taking a short-acting insulin (e.g., regular human insulin, insulin lispro, or insulin aspart) or oral antidiabetic agents (e.g., a sulfonylurea, metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, or a metiglinide), the subject must have been receiving these medications for at least 2 months prior to screening.
- For subjects taking an oral antidiabetic agent, the dose must be unchanged for the 2 weeks (4 weeks for a thiazolidinedione) prior to screening and should not be expected to be changed from the screening visit (day 14) through the final visit (day 11). The dose of any short-acting insulin may be changed if medically indicated.
- Males or non-pregnant females between the ages of 6 and 75 years; women must be postmenopausal for more than 2 years, surgically sterile, or agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
- Ability and willingness to perform blood glucose profiles using a plasma glucose meter provided at home over 11 consecutive days.
Key exclusion criteria (11 listed)
- Use of any other intermediate- or long-acting insulin (e.g., NPH, Ultralenter, Lenter) within the last 2 months prior to screening.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., systemic corticosteroids).
- History of hypoglycemia unawareness.
- Pregnancy (as determined by a serum pregnancy test at the screening visit).
- Breast-feeding.
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
Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days
Time frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
5 secondary outcomes
Compare % subjects with glucose measurements < or = to 72 mg/dL & < or = to 36 mg/dL at any point of the 8-point glucose profile during 3 consecutive days
Time frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the mean daily rate of hypoglycemia during 3 consecutive days
Time frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the changes from baseline in glucose values at each specific measurement time of the 8-point glucose profile during 3 consecutive days
Time frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To compare the incidence of symptomatic hypoglycemia
Time frame: at any time during 3 consecutive days before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime
To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations
Time frame: at any time during 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 28 Mar 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.
Judith Diaz 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 in people with Diabetes Mellitus, run by Sanofi at 1 site in Mexico.
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 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 28 Mar 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 Mexico. 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?
Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days (time frame: before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime). 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 28 Mar 2008.