Type 1 Diabetes MellitusPhase 3Lantus-P-CNNCT01223131
Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old.
A Phase 3 study testing Insulin glargine (HOE901) and NPH insulin in people with Type 1 Diabetes Mellitus, run by Sanofi at 10 sites in China.
Trial summary
Primary Objective: 6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glargine (HOE901) and NPH insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 10 sitesChina
- Study dates
- Feb 2011to Mar 2014
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.
Who cannot join
- Treatment with oral or parenteral glucose-lowering medications other than insulin.
- HbA1c < 7% or > 12 % at screening.
- 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
10 sites in 1 country.
10 sites in 1 country
China10 sites
Investigational Site Number 156006
Beijing, 100020
Investigational Site Number 156001
Beijing, 100045
Investigational Site Number 156007
Beijing, 100730
Investigational Site Number 156009
Changsha, 410011
Investigational Site Number 156008
Guangzhou, 510630
Investigational Site Number 156004
Hangzhou, 310003
Investigational Site Number 156016
Shanghai, 200040
Investigational Site Number 156005
Shanghai, 201102
Investigational Site Number 156019
Taiyuan, 030013
Investigational Site Number 156002
Wuhan, 430030
About this study
Official title: A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
Primary Objective:
6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.
Read more
Secondary Objectives:
- To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:
- Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
- Fasting blood glucose (FBG),
- Nocturnal blood glucose (BG),
- 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
- Daily total insulin dose and basal insulin dose,
- Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
- To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
- To assess anti-insulin and anti-glargine antibody development in both groups.
- To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing
Read the detailed description
The study duration for each patient is 28 weeks +/- 7 day broken down as follows:
- Screening phase: up to 2 weeks
- Run-in phase: 1 week
- Treatment phase: 24 weeks
- Follow-up: 1 week
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glargine (HOE901), NPH insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargine (HOE901)Drug
Pharmaceutical form:aqueous solution for injection
Route of administration: Subcutaneous
NPH insulinDrug
Pharmaceutical form:aqueous solution for injection
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine | Experimental | injection once daily at bedtime Receives: Drug: Insulin glargine (HOE901) |
| NPH insulin | Active comparator | injection once daily at bedtime or twice daily in the morning and at bedtime Receives: Drug: NPH insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change of glycosylated hemoglobin (HbA1c)
Measured: from baseline to week 24
Secondary outcomes (7)
Percentage of patients reaching HbA1c < 7.5%
Measured: at week 24
Change in Fasting Blood Glucose (FBG)
Measured: from baseline to week 24
Change in nocturnal Blood Glucose (BG)
Measured: from baseline to week 24
Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)
Measured: from baseline to week 24
Change in total insulin dose and basal insulin dose
Measured: from baseline to week 24
Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.
Measured: during 24-week treatment period
Anti-glargine and anti-human insulin antibody assessment
Measured: at screening, week 4, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2014
- Study completionMar 2014
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 Type 1 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223131
- Sponsor's protocol ID
- EFC11681
- Other IDs
- U1111-1116-3661
- Acronym
- Lantus-P-CN
- Status last verified
- Mar 2014
- First submitted
- 15 Oct 2010
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu M, Zhou Z, Yan J, Li P, Song W, Fu J, Chen X, Zhao W, Xi L, Luo X, Sha L, Deng X, Gong C. A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus. BMC Endocr Disord. 2016 Nov 26;16(1):67. doi: 10.1186/s12902-016-0146-2.
PubMed 27887605
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
- ClinicalTrials.gov ID
- NCT01223131
- Acronym / sponsor ID
- Lantus-P-CN / EFC11681
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Oct 2010 (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 Objective:
6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.
Secondary Objectives:
- To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:
- Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c < 7.5%,
- Fasting blood glucose (FBG),
- Nocturnal blood glucose (BG),
- 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
- Daily total insulin dose and basal insulin dose,
- Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
- To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
- To assess anti-insulin and anti-glargine antibody development in both groups.
- To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing
Detailed description
The study duration for each patient is 28 weeks +/- 7 day broken down as follows:
- Screening phase: up to 2 weeks
- Run-in phase: 1 week
- Treatment phase: 24 weeks
- Follow-up: 1 week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine | Experimental | Drug: Insulin glargine (HOE901)injection once daily at bedtime |
| NPH insulin | Active comparator | Drug: NPH insulininjection once daily at bedtime or twice daily in the morning and at bedtime |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Paediatric patients diagnosed with T1DM aged at least 6 years to less than 18 years at screening.
Key exclusion criteria (3 listed)
- Treatment with oral or parenteral glucose-lowering medications other than insulin.
- HbA1c < 7% or > 12 % at screening.
- 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 glargine (HOE901)Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous | Drug | Insulin glargine |
| NPH insulinPharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous | Drug | NPH insulin |
Primary outcome
Absolute change of glycosylated hemoglobin (HbA1c)
Time frame: from baseline to week 24
7 secondary outcomes
Percentage of patients reaching HbA1c < 7.5%
Time frame: at week 24
Change in Fasting Blood Glucose (FBG)
Time frame: from baseline to week 24
Change in nocturnal Blood Glucose (BG)
Time frame: from baseline to week 24
Change in 24-hour blood glucose profile based on 8-point self-monitoring blood glucose (SMBG)
Time frame: from baseline to week 24
Change in total insulin dose and basal insulin dose
Time frame: from baseline to week 24
Rate of asymptomatic and/or symptomatic, severe, nocturnal, nocturnal symptomatic hypoglycemia.
Time frame: during 24-week treatment period
Anti-glargine and anti-human insulin antibody assessment
Time frame: at screening, week 4, week 24
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 1 Apr 2014.
- Derived from this study: PubMed 27887605Liu M, Zhou Z, Yan J, Li P, Song W, Fu J, Chen X, Zhao W, Xi L, Luo X, Sha L, Deng X, Gong C. A randomised, open-labelstudy of insulin glargine or neutral protamine Hagedorn insulin in Chinese paediatric patients with type 1 diabetes mellitus. BMC Endocr Disord. 2016 Nov 26;16(1):67. doi: 10.1186/s12902-016-0146-2.
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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.
Clinical Sciences & Operations study director
Sanofi
10 sites 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 glargine (HOE901) and NPH insulin in people with Type 1 Diabetes Mellitus, run by Sanofi at 10 sites 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 1 inclusion and 3 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 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Absolute change of glycosylated hemoglobin (HbA1c) (time frame: from baseline to week 24). 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 NCT01223131, 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 1 Apr 2014.