Diabetes Mellitus, Type 2Phase 3NCT00135057
Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
A Phase 3 study testing insulin glulisine and insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.
Trial summary
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- insulin glulisine and insulin glargine
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus for at least six months; 18 to 70 years of age, inclusive.
- A1c ≥ 7.0% and ≤ 10% at screening
- At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections) +/- metformin prior to study entry. (Note: Subjects receiving insulin glargine [Lantus] twice a day [split dose] will be considered as being on one injection only.)
- Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
- Negative glutamic acid decarboxylase (GAD) autoantibodies
- Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least four times a day, and at least 7 times daily during the 7-point blood glucose (BG) profile measurement days
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- Ability and willingness to adhere to, and be compliant with, the study protocol
- Must be able to read English at the sixth grade level in order to complete the patient-reported outcomes component of the study.
- Signed informed consent
Who cannot join
- Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (within the 3 months before study entry) except for insulin and/or insulin analogues with or without metformin
- Planned pregnancy; or pregnant or lactating females.
- For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmoL) for females
- Serum creatinine ≥ 3.0 mg/dL (266 µmol/L)
- Any clinically significant renal disease (other than proteinuria) or hepatic disease
- Serum ALT or AST levels greater than 2.5 X the upper limit of normal
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- Any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ)
- Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Diagnosis of impaired dexterity or vision rendering the subject unable to administer multiple daily injections (MDIs)
- Cardiac status New York Heart Association (NYHA) III-IV
- Hypersensitivity to Lantus or insulin glulisine (Apidra) or any of their components
- Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study.
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- insulin glulisine, insulin 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.
insulin glulisineDrug
insulin glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startApr 2004
- Study completionAug 2005
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Barch, B.S., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135057
- Sponsor's protocol ID
- HMR1964A_3502
- Status last verified
- Jan 2011
- First submitted
- 23 Aug 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Publications
Bergenstal RM, Johnson M, Powers MA, Wynne A, Vlajnic A, Hollander P, Rendell M. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008 Jul;31(7):1305-10. doi: 10.2337/dc07-2137. Epub 2008 Mar 25.
PubMed 18364392
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Glulisine Administered in a Fixed Bolus Regimen Versus Variable Bolus Regimen Based on Carbohydrate Counting in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin
- ClinicalTrials.gov ID
- NCT00135057
- Acronym / sponsor ID
- HMR1964A_3502
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Aug 2005
- First posted
- 25 Aug 2005 (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 purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mealtime insulin following a variable bolus insulin regimen (based on carbohydrate counting) versus a fixed bolus insulin regimen, with insulin glargine as basal insulin in both arms of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of type 2 diabetes mellitus for at least six months; 18 to 70 years of age, inclusive.
- A1c ≥ 7.0% and ≤ 10% at screening
- At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections) +/- metformin prior to study entry. (Note: Subjects receiving insulin glargine [Lantus] twice a day [split dose] will be considered as being on one injection only.)
- Willingness of subject to discontinue other anti-diabetic drug treatments and to remain off them through the entire study
- Negative glutamic acid decarboxylase (GAD) autoantibodies
Key exclusion criteria (14 listed)
- Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (within the 3 months before study entry) except for insulin and/or insulin analogues with or without metformin
- Planned pregnancy; or pregnant or lactating females.
- For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmoL) for females
- Serum creatinine ≥ 3.0 mg/dL (266 µmol/L)
- Any clinically significant renal disease (other than proteinuria) or hepatic disease
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 | – |
| insulin glargine | Drug | – |
Primary outcome
Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count
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 11 Jan 2011.
- Derived from this study: PubMed 18364392Bergenstal RM, Johnson M, Powers MA, Wynne A, Vlajnic A, Hollander P, Rendell M. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008 Jul;31(7):1305-10. doi: 10.2337/dc07-2137. Epub 2008 Mar 25.
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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.
Karen Barch, B.S. 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 and insulin glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.
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 9 inclusion and 14 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 11 Jan 2011. 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 United States. 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?
Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count. 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 NCT00135057, 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 11 Jan 2011.