Back to resultsPatient 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 (Pen Preference)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
- 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
- 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)
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lantus (insulin glargine) vial & syringe
Lantus (insulin glargine) SoloSTAR pen
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
Change in Fasting Plasma Glucose (FPG)
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Change in Lantus Dose Injected Per Day
Percentage of Patients Achieving HbA1c Goal
Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)
Time to First Observation of HbA1c <7%
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01226043
Brief Title
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
Acronym
Pen Preference
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lantus (insulin glargine) vial & syringe
Arm Type
Experimental
Arm Description
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.
Arm Title
Lantus (insulin glargine) SoloSTAR pen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus
Intervention Description
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Patient Overall Preference
Description
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
Time Frame
At week 4 (end of crossover phase)
Secondary Outcome Measure Information:
Title
Patient Preference Composite Score
Description
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.
Time Frame
At week 4 (end of crossover phase)
Title
Healthcare Professional's (HCP) Recommendation
Description
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
Time Frame
At week 4 (end of crossover phase)
Title
Change in Fasting Plasma Glucose (FPG)
Time Frame
From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Title
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Time Frame
At week 10 (end of re-randomization phase)
Title
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)
Title
Percentage of Patients Achieving HbA1c Goal
Description
Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)
Time Frame
measured at week 40 or at study discontinuation
Title
Time to First Observation of HbA1c <7%
Time Frame
From week 10 to week 40 (observational phase)
Title
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Time Frame
From baseline to week 4 (crossover phase)
Title
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Time Frame
From week 4 to week 10 (re-randomization phase)
Title
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Time Frame
From week 10 to week 40 (observational phase)
Other Pre-specified Outcome Measures:
Title
Number of Patients With Hypoglycemic Events
Description
The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).
Time Frame
each study phase (crossover, re-randomization, observational) up to 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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