Diabetes Mellitus Type 2Phase 3NCT02227212
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
A Phase 3 study testing Insulin glargine U300 (new formulation of insulin glargine) HOE901 in people with Diabetes Mellitus Type 2, run by Sanofi at 7 sites in Germany.
Trial summary
Primary Objective: To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Insulin glargine U300 (new formulation of insulin glargine) HOE901
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesGermany
- Study dates
- Aug 2014to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate.
- Signed written informed consent.
Who cannot join
- Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
- Age <18 years at the time of screening.
- Body Mass Index (BMI) >40 kg/m2.
- Diabetes other than T2DM.
- History of T2DM for less than 1 year before screening.
- Less than 6 months anti-hyperglycemic treatment before screening.
Show all 16Show fewer
- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
- Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
- Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
- Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
- Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
- Any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective National Product labeling.
- Latest eye examination by an ophthalmologist >12 months prior to inclusion.
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.
- 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
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Investigational Site Number 276011
Augsburg, 86150
Investigational Site Number 276008
Berlin, 10115
Investigational Site Number 276009
Essen, 45355
Investigational Site Number 276002
Hamburg, 22607
Investigational Site Number 276001
Münster, 48145
Investigational Site Number 276007
Potsdam, 14469
Investigational Site Number 276004
Wangen, 88239
About this study
Official title: A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM
Primary Objective:
To demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.
Secondary Objectives:
To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.
The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.
Read the detailed description
The total study duration for a participants can be approximately up to 10 weeks.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Insulin glargine U300 (new formulation of insulin glargine) HOE901
- 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 glargine U300 (new formulation of insulin glargine) HOE901Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine U300 | Experimental | Once daily subcutaneous injection for 4 weeks Receives: Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease-of-use / ease of learning questionnaire
Measured: Day 1, Day 7 , 4-weeks
Secondary outcomes (10)
Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Measured: Baseline, week 4
Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Measured: Baseline, week 4
Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
Measured: Baseline, week 4
Number of participants with Product Technical Complaints (PTC)
Measured: Baseline to week 4
Number of participants with adverse events and hypoglycemic events related to PTC
Measured: Baseline to week 4
Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)
Measured: Baseline, week 4
Number of participants with adverse events
Measured: screening to week 6
Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association
Measured: screening to week 6
Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)
Measured: screening, baseline, week 4
Number of participants with site injection site reactions / hypersensitivity reactions
Measured: baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT02227212
- Sponsor's protocol ID
- PDY14065
- Other IDs
- 2014-001253-16, U1111-1155-7309, 2014
- Status last verified
- Dec 2014
- First submitted
- 26 Aug 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pohlmeier H, Berard L, Brulle-Wohlhueter C, Wu J, Dahmen R, Nowotny I, Klonoff D. Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naive People With Type 2 Diabetes. J Diabetes Sci Technol. 2017 Mar;11(2):263-269. doi: 10.1177/1932296816668877. Epub 2016 Sep 25.
PubMed 27664062
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center,Open-Label, Single-Arm, Multiple Dose Study With HOE901-U300 to Assess The Ease of Use And Safety of a New U300 Pen Injector in Insulin-Naïve Patients With T2DM
- ClinicalTrials.gov ID
- NCT02227212
- Acronym / sponsor ID
- PDY14065
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Aug 2014 (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 demonstrate the ease of use of the U300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week once-daily dosing regimen with HOE901-U300.
Secondary Objectives:
To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.
The safety and usability of the U300 pen injector. The glycemic control with the U300 pen injector. The safety of HOE901-U300.
Detailed description
The total study duration for a participants can be approximately up to 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine U300 | Experimental | Drug: Insulin glargine U300 (new formulation of insulin glargine) HOE901Once daily subcutaneous injection for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate.
- Signed written informed consent.
Key exclusion criteria (16 listed)
- Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
- Age <18 years at the time of screening.
- Body Mass Index (BMI) >40 kg/m2.
- Diabetes other than T2DM.
- History of T2DM for less than 1 year before screening.
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 U300 (new formulation of insulin glargine) HOE901Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Insulin glargine U300 |
Primary outcome
Ease-of-use / ease of learning questionnaire
Time frame: Day 1, Day 7 , 4-weeks
10 secondary outcomes
Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Time frame: Baseline, week 4
Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
Time frame: Baseline, week 4
Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
Time frame: Baseline, week 4
Number of participants with Product Technical Complaints (PTC)
Time frame: Baseline to week 4
Number of participants with adverse events and hypoglycemic events related to PTC
Time frame: Baseline to week 4
Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)
Time frame: Baseline, week 4
Number of participants with adverse events
Time frame: screening to week 6
Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association
Time frame: screening to week 6
Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)
Time frame: screening, baseline, week 4
Number of participants with site injection site reactions / hypersensitivity reactions
Time frame: baseline to week 6
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 3 Dec 2014.
- Derived from this study: PubMed 27664062Pohlmeier H, Berard L, Brulle-Wohlhueter C, Wu J, Dahmen R, Nowotny I, Klonoff D. Ease of Use of the Insulin Glargine 300 U/mL Pen Injector in Insulin-Naive People With Type 2 Diabetes. J Diabetes Sci Technol. 2017 Mar;11(2):263-269. doi: 10.1177/1932296816668877. Epub 2016 Sep 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.
Clinical Sciences & Operations study director
Sanofi
7 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 U300 (new formulation of insulin glargine) HOE901 in people with Diabetes Mellitus Type 2, run by Sanofi at 7 sites in Germany.
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 2 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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?
Ease-of-use / ease of learning questionnaire (time frame: Day 1, Day 7 , 4-weeks). 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 NCT02227212, 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 3 Dec 2014.