Diabetes Mellitus, Type 2Phase 4Basal PlusNCT00360698
Insulin Glulisine in Type 2 Diabetic Patients
A Phase 4 study testing Insulin Glargine, Glimepiride and Insulin Glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi at 3 sites in 3 countries.
Trial summary
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine, Glimepiride and Insulin Glulisine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2006to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Mellitus, Type 2
- 25 < BMI < 45 kg/m²
- 7,5% < HbA1c < 9%
- Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months
Who cannot join
- Type 1 diabetes mellitus
- Treatment with OADs only
- Treatment with thiazolidinediones, with exenatide or with pramlintide
- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- Active proliferative diabetic retinopathy,
- Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
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- Breast-feeding
- History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
- Treatment with systemic corticosteroids in the 3 months prior to study entry
- Treatment with any investigational product in the 2 months prior to study entry
- Previous treatment with insulin glulisine
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- Impaired hepatic function
- Impaired renal function
- History of drug or alcohol abuse
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, Glimepiride, Insulin Glulisine, 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.
Insulin GlargineDrug
One daily injection at bedtime
GlimepirideDrug
At same dosage as during the run-in period
Insulin GlulisineDrug
One bolus given before the main meal
MetforminDrug
At same dosage as during the run-in period
| Study group | Role | What they receive |
|---|---|---|
| insulin glulisine+insulin glargine+metformin+glimepiride | Other | Bolus arm Receives: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Insulin Glulisine; Drug: Metformin |
| insulin glargine+metformin+glimepiride | Other | Control arm Receives: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%
Measured: at the end of treatment (week 24)
Secondary outcomes (10)
Glycosylated Haemoglobin (HbA1c) Value
Measured: at the end of treatment (week 24)
Change in Glycosylated Haemoglobin (HbA1c) Value
Measured: from baseline to the end of treatment (week 24)
Daily Mean Plasma Glucose
Measured: at the end of treatment (week 24)
Change in Daily Mean Plasma Glucose
Measured: from baseline to the end of treatment (week 24)
Change in Weight
Measured: from baseline to the end of treatment (week 24)
Daily Dose of Insulin Glargine
Mean of 3 daily doses reported during the week prior to the final visit
Measured: at the end of treatment (week 24)
Daily Dose of Insulin Glulisine
Mean of 3 daily doses reported during the week prior to the final visit
Measured: at the end of treatment (week 24)
Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
Measured: during treatment period (12 weeks)
Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
Measured: during treatment period (12 weeks)
Rate of Severe Symptomatic Hypoglycemia
Measured: during treatment period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- PILORGET Valérie, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360698
- Sponsor's protocol ID
- HMR1964A_4002
- Other IDs
- EUDRACT # : 2005-002614-38
- Acronym
- Basal Plus
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2006
- Last updated
- 8 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.
- ClinicalTrials.gov ID
- NCT00360698
- Acronym / sponsor ID
- Basal Plus / HMR1964A_4002
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 7 Aug 2006 (estimated)
- Results
- Posted 2 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin glulisine+insulin glargine+metformin+glimepiride | Other | Drug: Insulin Glargine, Drug: Glimepiride, Drug: Insulin Glulisine, Drug: MetforminBolus arm |
| insulin glargine+metformin+glimepiride | Other | Drug: Insulin Glargine, Drug: Glimepiride, Drug: MetforminControl arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes Mellitus, Type 2
- 25 < BMI < 45 kg/m²
- 7,5% < HbA1c < 9%
- Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months
Key exclusion criteria (17 listed)
- Type 1 diabetes mellitus
- Treatment with OADs only
- Treatment with thiazolidinediones, with exenatide or with pramlintide
- Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- Active proliferative diabetic retinopathy,
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 GlargineOne daily injection at bedtime | Drug | insulin glargine+metformin+glimepiride, insulin glulisine+insulin glargine+metformin+glimepiride |
| GlimepirideAt same dosage as during the run-in period | Drug | insulin glargine+metformin+glimepiride, insulin glulisine+insulin glargine+metformin+glimepiride |
| Insulin GlulisineOne bolus given before the main meal | Drug | insulin glulisine+insulin glargine+metformin+glimepiride |
| MetforminAt same dosage as during the run-in period | Drug | insulin glargine+metformin+glimepiride, insulin glulisine+insulin glargine+metformin+glimepiride |
Primary outcome
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
Time frame: at the end of treatment (week 24)
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%
10 secondary outcomes
Glycosylated Haemoglobin (HbA1c) Value
Time frame: at the end of treatment (week 24)
Change in Glycosylated Haemoglobin (HbA1c) Value
Time frame: from baseline to the end of treatment (week 24)
Daily Mean Plasma Glucose
Time frame: at the end of treatment (week 24)
Change in Daily Mean Plasma Glucose
Time frame: from baseline to the end of treatment (week 24)
Change in Weight
Time frame: from baseline to the end of treatment (week 24)
Daily Dose of Insulin Glargine
Time frame: at the end of treatment (week 24)
Daily Dose of Insulin Glulisine
Time frame: at the end of treatment (week 24)
Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
Time frame: during treatment period (12 weeks)
Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL
Time frame: during treatment period (12 weeks)
Rate of Severe Symptomatic Hypoglycemia
Time frame: during treatment period (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
PILORGET Valérie, MD study director
Sanofi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Glargine, Glimepiride and Insulin Glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi at 3 sites in 3 countries.
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 4 inclusion and 17 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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Russia, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% (time frame: at the end of treatment (week 24)). 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 Aug 2011.