Diabetes MellitusPhase 3NCT00046501
Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
A Phase 3 study testing Lantus (insulin glargine [rDNA origin] injection), Humulin N and Humulin L in people with Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro) Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Lantus (insulin glargine [rDNA origin] injection), Humulin N and Humulin L
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Type 1 diabetes treated with insulin only for at least 1 year,
- with a Tanner stage of ≥ 2,
- had evidence of decreased insulin secretory capacity (fasting C-peptide concentration ≤0.5 mmol/L) and 7.0%≤A1c≤9.5% at screening.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study
The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
- Conditions
- Diabetes Mellitus
- Being tested
- Lantus (insulin glargine [rDNA origin] injection), Humulin N, Humulin L, Lispro
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lantus (insulin glargine [rDNA origin] injection)Drug
Humulin NDrug
Humulin LDrug
LisproDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure change in glycemic control as measured by hemoglobin A1c (A1c).
Measured: from baseline to endpoint (last available post-treatment assessment)
Secondary outcomes (11)
Change in A1c
Measured: from baseline to individual study time points
Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5%
Measured: During the study conduct
Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined
Measured: from baseline to endpoint
Change in urinary spot random microalbumin-to-creatinine (A/C) ratio
Measured: from baseline to endpoint
Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined
Measured: from baseline to endpoint
Change in average basal insulin doses
Measured: from baseline to endpoint
Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs])
Measured: from baseline to endpoint
Change in glucose
Measured: from baseline to endpoint
Occurrence of hypoglycemia
Measured: from the informed consent signature to the end of the study
Adverse events (AEs)
Measured: from the informed consent signature to the end of the study
Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI)
Measured: from the informed consent signature to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2002 (estimated)
- Study startNov 2002
- Primary completionFeb 2005
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
- 250 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Doug Green, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046501
- Sponsor's protocol ID
- HOE901_4030
- Status last verified
- Jan 2011
- First submitted
- 30 Sep 2002
- Last updated
- 11 Jan 2011
- Results posted
- No
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
- Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study
- ClinicalTrials.gov ID
- NCT00046501
- Acronym / sponsor ID
- HOE901_4030
- Conditions
- Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Feb 2005 (actual)
- First posted
- 2 Oct 2002 (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 the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 diabetes treated with insulin only for at least 1 year,
- with a Tanner stage of ≥ 2,
- had evidence of decreased insulin secretory capacity (fasting C-peptide concentration ≤0.5 mmol/L) and 7.0%≤A1c≤9.5% at screening.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lantus (insulin glargine [rDNA origin] injection) | Drug | – |
| Humulin N | Drug | – |
| Humulin L | Drug | – |
| Lispro | Drug | – |
Primary outcome
to measure change in glycemic control as measured by hemoglobin A1c (A1c).
Time frame: from baseline to endpoint (last available post-treatment assessment)
11 secondary outcomes
Change in A1c
Time frame: from baseline to individual study time points
Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5%
Time frame: During the study conduct
Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined
Time frame: from baseline to endpoint
Change in urinary spot random microalbumin-to-creatinine (A/C) ratio
Time frame: from baseline to endpoint
Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined
Time frame: from baseline to endpoint
Change in average basal insulin doses
Time frame: from baseline to endpoint
Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs])
Time frame: from baseline to endpoint
Change in glucose
Time frame: from baseline to endpoint
Occurrence of hypoglycemia
Time frame: from the informed consent signature to the end of the study
Adverse events (AEs)
Time frame: from the informed consent signature to the end of the study
Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI)
Time frame: from the informed consent signature to the end of the study
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.
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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.
Doug Green 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 Lantus (insulin glargine [rDNA origin] injection), Humulin N and Humulin L in people with Diabetes Mellitus, 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 4 inclusion and 0 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?
to measure change in glycemic control as measured by hemoglobin A1c (A1c). (time frame: from baseline to endpoint (last available post-treatment assessment)). 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 11 Jan 2011.