Diabetes Mellitus, Type 1Phase 3NCT00290979
Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
A Phase 3 study testing insulin glulisine in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Japan.
Trial summary
To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint. To compare the safety of HMR1964 with insulin lispro. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin glulisine
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2004to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women with type 1 diabetes mellitus, an HbA1C range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.
Who cannot join
- Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
- Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
- Subjects who were treated with another investigational product within 12 weeks prior to informed consent
- Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
- Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult
- Subjects who have undergone pancreatectomy or pancreas/islet cell transplant
Show all 16Show fewer
- Night shift workers
- Subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
- Subjects who have previously been treated with HMR1964
- Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
- Female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hCG) level > 0.7 mIU/mL as determined by central laboratory, SRL Medisearch Inc., during screening phase]
- Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
- Subjects with history of alcohol abuse
- Subjects with hypersensitivity to insulin preparations
- Subjects with impaired hepatic function (SGOT or SGPT ³=<80 IU/L determined by central laboratory, SRL Medisearch Inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dL determined by central laboratory, SRL Medisearch Inc., during screening phase)
- Subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-inferiority Study, for 28 Weeks
- To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
- To compare the safety of HMR1964 with insulin lispro.
Read the detailed description
- To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
- To collect 6-month safety data of HMR1964.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- insulin glulisine
- Keywords
- HMR1964, insulin glulisine, Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glulisineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
Secondary outcomes (1)
6-month safety data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 250 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Masayoshi KOYAMA, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290979
- Sponsor's protocol ID
- EFC6167
- Status last verified
- Mar 2009
- First submitted
- 10 Feb 2006
- Last updated
- 26 Aug 2009
- Results posted
- No
Publications
Kawamori R, Kadowaki T, Ishii H, Iwasaki M, Iwamoto Y. Efficacy and safety of insulin glulisine in Japanese patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2009 Sep;11(9):891-9. doi: 10.1111/j.1463-1326.2009.01086.x. Epub 2009 Jul 13.
PubMed 19614947
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-inferiority Study, for 28 Weeks
- ClinicalTrials.gov ID
- NCT00290979
- Acronym / sponsor ID
- EFC6167
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- HMR1964, insulin glulisine, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- First posted
- 13 Feb 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.
- To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
- To compare the safety of HMR1964 with insulin lispro.
Detailed description
- To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
- To collect 6-month safety data of HMR1964.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women with type 1 diabetes mellitus, an HbA1C range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.
Key exclusion criteria (16 listed)
- Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
- Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
- Subjects who were treated with another investigational product within 12 weeks prior to informed consent
- Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
- Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult
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 glulisine | Drug | – |
Primary outcome
Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
1 secondary outcome
6-month safety data
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 26 Aug 2009.
- Results publication: PubMed 19614947Kawamori R, Kadowaki T, Ishii H, Iwasaki M, Iwamoto Y. Efficacy and safety of insulin glulisine in Japanese patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2009 Sep;11(9):891-9. doi: 10.1111/j.1463-1326.2009.01086.x. Epub 2009 Jul 13.
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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.
Masayoshi KOYAMA 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 in people with Diabetes Mellitus, Type 1, run by Sanofi at 1 site in Japan.
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 1 inclusion and 16 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 26 Aug 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 Japan. 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?
Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290979, which also lists 1 linked publication.
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 26 Aug 2009.