Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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) Seconda...
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 parti...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT01226043
Start Date
October 1 2010
End Date
May 1 2012
Last Update
August 12 2013
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807