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 (Pen Preference)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01226043
First received: October 19, 2010
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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)

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patient Overall Preference [ Time Frame: At week 4 (end of crossover phase) ] [ Designated as safety issue: No ]

    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 [ Time Frame: At week 4 (end of crossover phase) ] [ Designated as safety issue: No ]

    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 [ Time Frame: At week 4 (end of crossover phase) ] [ Designated as safety issue: No ]

    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) [ Time Frame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase) ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL [ Time Frame: At week 10 (end of re-randomization phase) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving HbA1c Goal [ Time Frame: measured at week 40 or at study discontinuation ] [ Designated as safety issue: No ]
    Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)

  • Time to First Observation of HbA1c <7% [ Time Frame: From week 10 to week 40 (observational phase) ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase [ Time Frame: From baseline to week 4 (crossover phase) ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase [ Time Frame: From week 4 to week 10 (re-randomization phase) ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinued Investigational Product During the Observational Phase [ Time Frame: From week 10 to week 40 (observational phase) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of Patients With Hypoglycemic Events [ Time Frame: each study phase (crossover, re-randomization, observational) up to 40 weeks ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 405
Study Start Date: October 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lantus (insulin glargine) vial & syringe
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.
Drug: Insulin Glargine
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous
Other Name: Lantus
Experimental: Lantus (insulin glargine) SoloSTAR pen
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.
Drug: Insulin Glargine
  • Pharmaceutical form: solution for injection
  • Route of administration: subcutaneous
Other Name: Lantus

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226043

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01226043     History of Changes
Other Study ID Numbers: LANTU_L_05191, U1111-1116-3054
Study First Received: October 19, 2010
Results First Received: May 3, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014