Diabetes Mellitus, Type 1Phase 3NCT00272090
Insulin Glargine in Type 1 Diabetes Mellitus
A Phase 3 study testing Insulin glargine in people with Diabetes Mellitus, Type 1, run by Sanofi.
Trial summary
The primary purpose of the protocol is to demonstrate that the new regimen (insulin glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the secondary purpose is to compare the two study… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin glargine
- How many people
- 489 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Dec 2005
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with type 1 diabetes mellitus for more than three years
- Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy
- HbA1c <= 9 % (measured by central Lab, with DCCT aligned standard method)
- Fasting C-Peptide <= 0,1nmol/L with FBG >126 mg/dl
- Body Mass Index (BMI) < 30 kg/m2
- Willingness to accept intensive insulin therapy
- Ability and willingness to perform SMBG using plasma glucose meter
- Female subjects must be postmenopausal or under adequate contraception as judged by the investigator (it may be oral contraceptives, intra-uterine device or surgical treatment) and must have a negative serum pregnancy test
Who cannot join
- Diabetes other than type 1 diabetic mellitus
- Type 1 diabetic patients with total insulin dose >= 1 IU/kg/day
- Serum creatinine > 1.5 mg/dl, or history of renal transplantation or current renal dialysis
- Congestive heart failure NYHA class II
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- Clinical evidence of active liver disease, or serum ALT/AST 2 times the upper limit of the normal range
Show all 26Show fewer
- Hypoglycemia unawareness
- Pregnancy or lactation
- Concomitant use of β-blockers, thiazides or systemic corticosteroids
- More than one episode of severe hypoglycemia with seizure or coma during the past year
- Likelihood of requiring treatment during the study period with any anti-diabetic drug other than the study drugs
- Failure to use adequate contraception (women of current reproductive potential only)
- Known hypersensitivity to insulin glargine, or any of the excipients
- Malignancy except basal cell carcinoma within the last five years
- Long lasting (> 2 weeks) treatment with systemic glucocorticoid therapy
- Known adrenal insufficiency (interferes with hypoglycemia counter-regulation)
- Known hemoglobinopathy or chronic anemia because it may interfere with Hb1Ac determination
- History of substance or alcohol abuse within the last two years or current addiction to substances of abuse including ethanol
- History of positive HIV test or Hepatitis B/C test
- Any usage outside of the current SPC (Summary of the Product Characteristics)
- Any clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease other than type 1 diabetic mellitus making implementation of the protocol or interpretation of the study results difficult
- History of demonstrable micro- and macro-angiopathic complications
- Pre-planned surgery during the study
- Blood donation of more than 500 ml during the previous 3 months for males or 6 months for females
- Smoker for previous 3 months
- Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry.
About this study
Official title: Italian Experience Trial for the Implementation of the Use of Lantus in Basal - Bolus Regimen in Type I Diabetes Mellitus Patients.
The primary purpose of the protocol is to demonstrate that the new regimen (insulin glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the secondary purpose is to compare the two study regimens as far as the glycemic control (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data, are concerned and to verify the safety of basal insulinization with Lantus.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin glargine
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
severe nocturnal hypoglycemias will be measured throughout the study period.
Secondary outcomes (3)
HbA1c will be measured at basal and 8/16 weeks after start of treatment
8 point glucose profile will be measured during last 2 weeks before each scheduled visit
severe hypoglycemias and nocturnal hypoglycemias will be measured throughout the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startNov 2002
- Primary completionDec 2005
- Study completionDec 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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- PAIZIS GEORGES, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272090
- Sponsor's protocol ID
- HOE901_3507
- Status last verified
- Jun 2011
- First submitted
- 2 Jan 2006
- 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
- Italian Experience Trial for the Implementation of the Use of Lantus in Basal - Bolus Regimen in Type I Diabetes Mellitus Patients.
- ClinicalTrials.gov ID
- NCT00272090
- Acronym / sponsor ID
- HOE901_3507
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 4 Jan 2006 (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.
The primary purpose of the protocol is to demonstrate that the new regimen (insulin glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-pro insulin ) in reducing the incidence of severe nocturnal hypoglycemia at the end point; the secondary purpose is to compare the two study regimens as far as the glycemic control (measured by HbA1c), the daily Mean Blood Glucose (MBG) and the mean amplitude of glycemic excursion (MAGE index), calculated on the basis of Self Monitoring Blood Glugose (SMBG) data, are concerned and to verify the safety of basal insulinization with Lantus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects with type 1 diabetes mellitus for more than three years
- Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy
- HbA1c <= 9 % (measured by central Lab, with DCCT aligned standard method)
- Fasting C-Peptide <= 0,1nmol/L with FBG >126 mg/dl
- Body Mass Index (BMI) < 30 kg/m2
Key exclusion criteria (26 listed)
- Diabetes other than type 1 diabetic mellitus
- Type 1 diabetic patients with total insulin dose >= 1 IU/kg/day
- Serum creatinine > 1.5 mg/dl, or history of renal transplantation or current renal dialysis
- Congestive heart failure NYHA class II
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
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
severe nocturnal hypoglycemias will be measured throughout the study period.
3 secondary outcomes
HbA1c will be measured at basal and 8/16 weeks after start of treatment
8 point glucose profile will be measured during last 2 weeks before each scheduled visit
severe hypoglycemias and nocturnal hypoglycemias will be measured throughout the study period.
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.
PAIZIS GEORGES, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin glargine in people with Diabetes Mellitus, Type 1, 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 8 inclusion and 26 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
severe nocturnal hypoglycemias will be measured throughout the study period.. 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.