Type 1 Diabetes MellitusPhase 1NCT01676233
Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
A Phase 1 study testing insulin glargine (HOE901) and insulin glargine- new formulation (HOE901) in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- insulin glargine (HOE901) and insulin glargine- new formulation (HOE901)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Who cannot join
- Age < 20 years at written informed consent;
- HbA1c < 6.5% or > 10.0% at screening
- Diabetes mellitus (DM) other than T1DM;
- Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
- Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
- Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit
- 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: A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
Primary Objective:
- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state
Secondary Objectives:
- To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
- To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
- To compare the occurrence of hypoglycemia between the 2 treatments;
- To assess the safety and tolerability of a new formulation of insulin glargine.
Read the detailed description
66 days
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- insulin glargine (HOE901), insulin glargine- new formulation (HOE901)
- 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: solution Route of administration: subcutaneous
insulin glargine- new formulation (HOE901)Drug
Pharmaceutical form: solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal Receives: Drug: insulin glargine (HOE901); Drug: insulin glargine- new formulation (HOE901) |
| Sequence 2 | Experimental | Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal Receives: Drug: insulin glargine (HOE901); Drug: insulin glargine- new formulation (HOE901) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Measured: Baseline, Day 28, Day 56
Secondary outcomes (4)
Hypoglycemia categorized by the definition of American Diabetes Association
Measured: Up to Day 56
Change in fasting plasma glucose from baseline to each treatment end by treatment
Measured: Baseline, Day 28, Day 56
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Measured: Baseline, Day 28, Day 56
Change in HbA1c from baseline to each treatment end by treatment
Measured: Baseline, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01676233
- Sponsor's protocol ID
- PDY12335
- Other IDs
- U1111-1129-3633
- Status last verified
- Aug 2013
- First submitted
- 28 Aug 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.
PubMed 26055218
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin
- ClinicalTrials.gov ID
- NCT01676233
- Acronym / sponsor ID
- PDY12335
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Aug 2012 (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:
- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state
Secondary Objectives:
- To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
- To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
- To compare the occurrence of hypoglycemia between the 2 treatments;
- To assess the safety and tolerability of a new formulation of insulin glargine.
Detailed description
66 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: insulin glargine (HOE901), Drug: insulin glargine- new formulation (HOE901)Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal |
| Sequence 2 | Experimental | Drug: insulin glargine (HOE901), Drug: insulin glargine- new formulation (HOE901)Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Key exclusion criteria (7 listed)
- Age < 20 years at written informed consent;
- HbA1c < 6.5% or > 10.0% at screening
- Diabetes mellitus (DM) other than T1DM;
- Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
- Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
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: solution Route of administration: subcutaneous | Drug | Sequence 1, Sequence 2 |
| insulin glargine- new formulation (HOE901)Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Sequence 1, Sequence 2 |
Primary outcome
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Time frame: Baseline, Day 28, Day 56
4 secondary outcomes
Hypoglycemia categorized by the definition of American Diabetes Association
Time frame: Up to Day 56
Change in fasting plasma glucose from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
Change in HbA1c from baseline to each treatment end by treatment
Time frame: Baseline, Day 28, Day 56
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 19 Aug 2013.
- Derived from this study: PubMed 26055218Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing insulin glargine (HOE901) and insulin glargine- new formulation (HOE901) in people with Type 1 Diabetes Mellitus, 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 7 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 19 Aug 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in 24-hour blood glucose profile measured by continuous glucose monitoring (time frame: Baseline, Day 28, Day 56). 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 NCT01676233, 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 19 Aug 2013.