Diabetes MellitusPhase 3NCT00467376
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
A Phase 3 study testing Insulin Glulisine, Lispro and Insulin Glargine in people with Diabetes Mellitus, run by Sanofi at 1 site in China.
Trial summary
Primary: To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Glulisine, Lispro and Insulin Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetic patients
- Measure HbA1c 6.5% to 11.0% at visit 1
- More than 3 months of continuous insulin treatment immediately prior to study entry
Who cannot join
- Pregnant women
- 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
1 site in 1 country.
About this study
Official title: 12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)
Primary:
- To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
- To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
- To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin Glulisine, Lispro, 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 GlulisineDrug
3 times a day before each meal
LisproDrug
3 times a day before each meal
Insulin GlargineDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of Insulin Glulisine Receives: Drug: Insulin Glulisine; Drug: Insulin Glargine |
| 2 | Active comparator | Administration of Lispro Receives: Drug: Lispro; Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic episodes
Measured: From the beginning to end of the study
Change in HbA1c
Measured: From baseline to endpoint
Adverse events
Measured: From the beginning to the end of study
Secondary outcomes (2)
Change in HbA1c
Measured: From baseline to weeks 12
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
Measured: from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jing Fu, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467376
- Sponsor's protocol ID
- APIDR_L_00348
- Status last verified
- Sep 2009
- First submitted
- 27 Apr 2007
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)
- ClinicalTrials.gov ID
- NCT00467376
- Acronym / sponsor ID
- APIDR_L_00348
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 30 Apr 2007 (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:
- To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
- To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
- To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin Glulisine, Drug: Insulin GlargineAdministration of Insulin Glulisine |
| 2 | Active comparator | Drug: Lispro, Drug: Insulin GlargineAdministration of Lispro |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 or type 2 diabetic patients
- Measure HbA1c 6.5% to 11.0% at visit 1
- More than 3 months of continuous insulin treatment immediately prior to study entry
Key exclusion criteria (2 listed)
- Pregnant women
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 Glulisine3 times a day before each meal | Drug | 1 |
| Lispro3 times a day before each meal | Drug | 2 |
| Insulin Glargineonce daily | Drug | 1, 2 |
Primary outcome
Hypoglycemic episodes
Time frame: From the beginning to end of the study
Change in HbA1c
Time frame: From baseline to endpoint
Adverse events
Time frame: From the beginning to the end of study
2 secondary outcomes
Change in HbA1c
Time frame: From baseline to weeks 12
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
Time frame: from baseline to week 12
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 15 Sep 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.
Jing Fu 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 3 study testing Insulin Glulisine, Lispro and Insulin Glargine in people with Diabetes Mellitus, run by Sanofi at 1 site in China.
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 3 inclusion and 2 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 15 Sep 2009. 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 China. 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 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?
Hypoglycemic episodes (time frame: From the beginning to end of the study). The study lists 3 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 15 Sep 2009.