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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226043
• Other study ID #: LANTU_L_05191
• Secondary ID: U1111-1116-3054
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2010
• Last updated: July 30, 2013
• Start date: October 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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:

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients With Hypoglycemic Events	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).	each study phase (crossover, re-randomization, observational) up to 40 weeks	Yes
Primary	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	At week 4 (end of crossover phase)	No
Secondary	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.	At week 4 (end of crossover phase)	No
Secondary	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	At week 4 (end of crossover phase)	No
Secondary	Change in Fasting Plasma Glucose (FPG)		From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)	No
Secondary	Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL		At week 10 (end of re-randomization phase)	No
Secondary	Change in Lantus Dose Injected Per Day		From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)	No
Secondary	Percentage of Patients Achieving HbA1c Goal	Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)	measured at week 40 or at study discontinuation	No
Secondary	Time to First Observation of HbA1c <7%		From week 10 to week 40 (observational phase)	No
Secondary	Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase		From baseline to week 4 (crossover phase)	No
Secondary	Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase		From week 4 to week 10 (re-randomization phase)	No
Secondary	Percentage of Patients Who Discontinued Investigational Product During the Observational Phase		From week 10 to week 40 (observational phase)	No