Diabetes Mellitus, Type 2Phase 4Pen PreferenceNCT01226043

Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective: To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM) Secondary Objectives: To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: 1 siteUnited States
Study dates: Oct 2010to May 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a confirmed diagnosis of type 2 diabetes mellitus who were treated with any combination of 2 or 3 oral antidiabetic drugs (OADs) at a stable dose for the preceding 3 months, including but not limited to:
Metformin + sulfonylurea + thiazolidinedione (Pioglitazone)
Metformin + sulfonylurea
Metformin + thiazolidinedione (Pioglitazone)
Metformin + dipeptidyl peptidase (DPPIV)
And for whom the Investigator/treating physician had decided that basal insulin was appropriate.
Patients who had signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form

Who cannot join

Patients less than 18 years or greater than 85 years of age (ie, have not reached the age of 86 at the screening visit)
Patients with a confirmed diagnosis of type 1 diabetes mellitus
Patients who were treated with insulin or who had been treated with insulin in the preceding 12 months with the exception of insulin treatment during hospitalization (ie, patients who received insulin while hospitalized could be included)
Patients whose screening HbA1c is <7% or >10%
Patients with current addiction or current alcohol / drug abuse
Patients with cardiac status New York Heart Association III-IV

Show all 17Show fewer

Patients with stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or unstable angina pectoris within the 12 months prior to screening
Patients with a diagnosis of dementia, severe visual or dexterity impairment
Patients with any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
Patients with concomitant disease or concomitant medication that could interfere with treatment or ability to answer questionnaires
Patients who were unable to self-inject
Patients who were taking or had been treated with Byetta® (exenatide) or other Glucagon-Like Peptide-1 agonists within 3 months before screening:
Patients who were pregnant or breastfeeding
Women of childbearing potential not protected by a highly effective contraceptive method of birth control (as defined for contraception in the Informed Consent Form and /or in a local protocol addendum) and/or who were unwilling or unable to be tested for pregnancy
Patients with impaired renal function as shown by serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL for females at screening
Patients with clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range (ULN)
Patients unlikely to comply with the protocol requirements (eg, illiterate, uncooperative, unable to return for scheduled visits, unlikely to complete the study)

Trial locations and contacts

1 site in 1 country.

United States1 site

Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: An Open Label Randomized Multicenter Study to Assess Patient Preference for and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients With Type 2 Diabetes Mellitus

Primary Objective:

To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

Secondary Objectives:

To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters:

Randomization/Crossover phase:

Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe

Re-randomization phase:

Change in Fasting Plasma Glucose (FPG) from week 4 to week 10
Percentage of patients achieving FPG<110 mg/dL at week 10
Change in Lantus dose injected per day (U) from week 4 to week 10

Observational phase:

Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40
Time to first observation of HbA1c<7% during the observational phase
Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device

All phases:

Percentage of patients who discontinue IP during each phase of the study
Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)

Read the detailed description

This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.

Conditions: Diabetes Mellitus, Type 2
Being tested: 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 GlargineDrug
Also called Lantus
- Pharmaceutical form: solution for injection
- Route of administration: subcutaneous

Study groups in NCT01226043
Study group	Role	What they receive
Lantus (insulin glargine) vial & syringe	Experimental	10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight. Receives: Drug: Insulin Glargine
Lantus (insulin glargine) SoloSTAR pen	Experimental	3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight. Receives: Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Overall Preference
The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d "Overall, what is your level of preference for each of the insulin delivery systems?"
5 points scale: from 1=Not preferred to 5= Always preferred
Measured: At week 4 (end of crossover phase)

Secondary outcomes (10)

Patient Preference Composite Score
The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire:
- Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar?
- Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin?
- Question 14c: How strongly would you prefer each insulin delivery system for long-term use?
Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15.
Measured: At week 4 (end of crossover phase)
Healthcare Professional's (HCP) Recommendation
The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: "Overall, how strongly would you recommend each of the insulin delivery systems for your patients?"
5 points scale: from 1= Not Recommended to 5= Recommended
Measured: At week 4 (end of crossover phase)
Change in Fasting Plasma Glucose (FPG)
Measured: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Measured: At week 10 (end of re-randomization phase)
Change in Lantus Dose Injected Per Day
Measured: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving HbA1c Goal
Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)
Measured: measured at week 40 or at study discontinuation
Time to First Observation of HbA1c <7%
Measured: From week 10 to week 40 (observational phase)
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Measured: From baseline to week 4 (crossover phase)
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Measured: From week 4 to week 10 (re-randomization phase)
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Measured: From week 10 to week 40 (observational phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2012

First posted21 Oct 2010 (estimated)
Study startOct 2010
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01226043
Sponsor's protocol ID: LANTU_L_05191
Other IDs: U1111-1116-3054
Acronym: Pen Preference
Status last verified: Jul 2013
First submitted: 19 Oct 2010
Last updated: 12 Aug 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Randomized Multicenter Study to Assess Patient Preference for and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01226043
Acronym / sponsor ID: Pen Preference / LANTU_L_05191
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 30 Jul 2013

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 assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

Secondary Objectives:

To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters:

Randomization/Crossover phase:

Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe

Re-randomization phase:

Change in Fasting Plasma Glucose (FPG) from week 4 to week 10
Percentage of patients achieving FPG<110 mg/dL at week 10
Change in Lantus dose injected per day (U) from week 4 to week 10

Observational phase:

Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40
Time to first observation of HbA1c<7% during the observational phase
Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device

All phases:

Percentage of patients who discontinue IP during each phase of the study
Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)

Detailed description

This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lantus (insulin glargine) vial & syringe	Experimental	Drug: Insulin Glargine10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
Lantus (insulin glargine) SoloSTAR pen	Experimental	Drug: Insulin Glargine3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients with a confirmed diagnosis of type 2 diabetes mellitus who were treated with any combination of 2 or 3 oral antidiabetic drugs (OADs) at a stable dose for the preceding 3 months, including but not limited to:
Metformin + sulfonylurea + thiazolidinedione (Pioglitazone)
Metformin + sulfonylurea
Metformin + thiazolidinedione (Pioglitazone)
Metformin + dipeptidyl peptidase (DPPIV)

Key exclusion criteria (17 listed)

Patients less than 18 years or greater than 85 years of age (ie, have not reached the age of 86 at the screening visit)
Patients with a confirmed diagnosis of type 1 diabetes mellitus
Patients who were treated with insulin or who had been treated with insulin in the preceding 12 months with the exception of insulin treatment during hospitalization (ie, patients who received insulin while hospitalized could be included)
Patients whose screening HbA1c is <7% or >10%
Patients with current addiction or current alcohol / drug abuse

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 GlargineAlso: Lantus* Pharmaceutical form: solution for injection * Route of administration: subcutaneous	Drug	Lantus (insulin glargine) SoloSTAR pen, Lantus (insulin glargine) vial & syringe

Primary outcome

Patient Overall Preference
Time frame: At week 4 (end of crossover phase)
The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d "Overall, what is your level of preference for each of the insulin delivery systems?" 5 points scale: from 1=Not preferred to 5= Always preferred

10 secondary outcomes

Patient Preference Composite Score
Time frame: At week 4 (end of crossover phase)
Healthcare Professional's (HCP) Recommendation
Time frame: At week 4 (end of crossover phase)
Change in Fasting Plasma Glucose (FPG)
Time frame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Time frame: At week 10 (end of re-randomization phase)
Change in Lantus Dose Injected Per Day
Time frame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving HbA1c Goal
Time frame: measured at week 40 or at study discontinuation
Time to First Observation of HbA1c <7%
Time frame: From week 10 to week 40 (observational phase)
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Time frame: From baseline to week 4 (crossover phase)
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Time frame: From week 4 to week 10 (re-randomization phase)
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Time frame: From week 10 to week 40 (observational phase)

Results and safety

Results posted to the registry on 30 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pen (Period 1) / Vial & Syringe (Period 2)	202	199
Vial &Syringe (Period 1) / Pen (Period 2)	203	194
SoloSTAR® Pen	0	0
Vial and Syringe	0	0

Primary outcome: Patient Overall Preference

Time frame: At week 4 (end of crossover phase). Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	SoloSTAR® Pen n = 388	Vial and Syringe n = 388
Value	4.75 (4.75)	2.45 (2.35 to 2.56)

SoloSTAR® Pen vs Vial and Syringe: Mean Difference (Net): 2.3 (95% CI 2.15 to 2.44), p <0.0001, ANOVA

Population analysed: The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: The median of exposure to each device was 14 days during the crossover phase. The median of exposure was 43 days in both arms during the re-randomization phase. During the observational phase, it was 209 days in the pen arm and 210 days in the vial arm.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Crossover Phase: SoloSTAR® Pen	4 of 396 (1%)	18 of 396 (4.5%)	Not reported
Crossover Phase: Vial and Syringe	1 of 399 (0.3%)	5 of 399 (1.3%)	Not reported
Re-randomization Phase: SoloSTAR® Pen	1 of 165 (0.6%)	12 of 165 (7.3%)	Not reported
Re-randomization Phase: Vial and Syringe	0 of 165 (0%)	14 of 165 (8.5%)	Not reported
Observational Phase: SoloSTAR® Pen	16 of 159 (10.1%)	35 of 159 (22%)	Not reported
Observational Phase: Vial and Syringe	14 of 153 (9.2%)	34 of 153 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 4 study testing 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 7 inclusion and 17 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 12 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient Overall Preference (time frame: At week 4 (end of crossover phase)). 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 NCT01226043.

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 12 Aug 2013.