Diabetes Mellitus, Type 2Phase 4NCT00272077
Insulin Glargine in Type 2 Diabetes Mellitus
A Phase 4 study testing Insuline glargine in people with Diabetes Mellitus, Type 2, run by Sanofi.
Trial summary
Primary objective: To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insuline glargine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2005to May 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus for at least 5 years;
- Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);
- HbA1c >= 8% and <= 11%;
- Body mass index (BMI) > 27 and < 35 kg/m2;
- Willingness and demonstrated ability to inject insulin;
- Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG);
Who cannot join
- Patients diagnosed with type 1 insulin dependent diabetes;
- Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels < 1 ng/ml;
- Cardiac status NYHA III-IV;
- Impaired renal function as shown by (but not limited to) serum creatinine >= 1.5 mg/dl for males or >= 1.4 mg/dl for females;
- Planned pregnancy, pregnant or lactating females;
- Failure to use adequate contraception (women of current reproductive potential only);
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- Any current malignancy, previous breast cancer, or malignant melanoma within the past 5 years;
- Diagnosis of dementia
- Hypersensitivity to insulin or any of their components or to metformin;
- Current or previous insulin therapy other than during hospitalisations;
- Inability or unwillingness to continue metformin at study dosages throughout the study;
- Treatment with intermittent doses of systemic steroids or large doses of inhaled steroids for the past one year (fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regime);
- Stroke, Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), or Angina Pectoris within the last 12 months;
- History of drug or alcohol abuse;
- Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;
About this study
Official title: Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment.
Primary objective:
To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).
Read more
Secondary objectives:
The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insuline 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.
Insuline glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
SMBG values
Measured: during the last 4 weeks before visit 3 (end of cycle 1) and visit 4
Secondary outcomes (8)
glycaemic control (HbA1c, fasting blood glucose, insulin and C-peptide),
Measured: During the study conduct
frequency of hypoglycaemias
Measured: During the study conduct
body weight
Measured: During the study conduct
final insulin dose
Measured: During the study conduct
lipid profile (serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
Measured: During the study conduct
urinary albumin-to-creatinine ratio
Measured: During the study conduct
standard meal test
Measured: during the study conduct
results of CGMS
Measured: During the study conduct
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 startApr 2005
- Primary completionMay 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
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
- NCT00272077
- Sponsor's protocol ID
- HOE901_3509
- Other IDs
- EudraCT # : 2004-002730-19
- Status last verified
- Dec 2009
- First submitted
- 2 Jan 2006
- Last updated
- 7 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment.
- ClinicalTrials.gov ID
- NCT00272077
- Acronym / sponsor ID
- HOE901_3509
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- May 2006 (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.
Primary objective:
To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).
Secondary objectives:
The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 diabetes mellitus for at least 5 years;
- Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);
- HbA1c >= 8% and <= 11%;
- Body mass index (BMI) > 27 and < 35 kg/m2;
- Willingness and demonstrated ability to inject insulin;
Key exclusion criteria (15 listed)
- Patients diagnosed with type 1 insulin dependent diabetes;
- Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels < 1 ng/ml;
- Cardiac status NYHA III-IV;
- Impaired renal function as shown by (but not limited to) serum creatinine >= 1.5 mg/dl for males or >= 1.4 mg/dl for females;
- Planned pregnancy, pregnant or lactating females;
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 |
|---|---|---|
| Insuline glargine | Drug | – |
Primary outcome
SMBG values
Time frame: during the last 4 weeks before visit 3 (end of cycle 1) and visit 4
8 secondary outcomes
glycaemic control (HbA1c, fasting blood glucose, insulin and C-peptide),
Time frame: During the study conduct
frequency of hypoglycaemias
Time frame: During the study conduct
body weight
Time frame: During the study conduct
final insulin dose
Time frame: During the study conduct
lipid profile (serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
Time frame: During the study conduct
urinary albumin-to-creatinine ratio
Time frame: During the study conduct
standard meal test
Time frame: during the study conduct
results of CGMS
Time frame: During the study conduct
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 7 Dec 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.
PAIZIS GEORGES, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insuline 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 15 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 7 Dec 2009. 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?
SMBG values (time frame: during the last 4 weeks before visit 3 (end of cycle 1) and visit 4). 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 7 Dec 2009.