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:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01226043
First received: October 19, 2010
Last updated: May 10, 2012
Last verified: May 2012
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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 wekk 10
Observational phase:
- percentage of patients achieving 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 Crossover Study to Assess Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial/Syringe Method of Insulin Glargine (Lantus) Injection Therapy in Patients With T2DM |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Patient preference [ Time Frame: at week 4 (end of crossover phase) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Healthcare professional recommendation [ Time Frame: at week 4 (end of crossover phase) ] [ Designated as safety issue: No ]
- Change in Fasting Plasma Glucose (FPG) [ Time Frame: from week 4 (baseline for re-randomization phase) to week 10 ] [ Designated as safety issue: No ]
- Percentage of patients achieving Fasting Plasma Glucose (FPG) <110 mg/dL [ Time Frame: at week 10 ] [ Designated as safety issue: No ]
- Change in Lantus dose injected per day [ Time Frame: from week 4 to week 10 ] [ Designated as safety issue: No ]
- Percentage of patients achieving HbA1c goal (<7%) [ Time Frame: at weeks 4, 16, 28 and 40, or at study discontinuation ] [ Designated as safety issue: No ]
- Time to first observation of HbA1c <7% [ Time Frame: from week 10 to week 40 (during observational phase) ] [ Designated as safety issue: No ]
- Percentage of patients who discontinue investigational product [ Time Frame: from week 10 to week 40 (during observational phase) ] [ Designated as safety issue: No ]
- percentage of patients who discontinue investigational product [ Time Frame: from week 0 to week 4, from week 4 to week 10 ] [ Designated as safety issue: No ]
| Enrollment: | 623 |
| 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
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 Dose regimen: once a day
Other Name: Lantus
|
|
Experimental: Lantus (Insulin glargine) SoloSTAR
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 Dose regimen: once a day
Other Name: Lantus SoloSTAR
|
Detailed Description:
This study consists 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 is 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 are currently being 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 + DPPIV And for whom the Investigator/treating physician has decided that basal insulin is appropriate.
Exclusion criteria:
- Patients with a confirmed diagnosis of type 1 diabetes mellitus
- who are currently being treated with insulin or who have been treated with insulin in the preceding 12 months with the exception of insulin treatment during hospitalization (ie, patients who received insulin while hospitalized may be included)
- whose screening HbA1c is <7% or >10%
- with current addiction or current alcohol / drug abuse
- with cardiac status New York Heart Association III-IV
- with stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or unstable angina pectoris within the 12 months prior to screening
- with a diagnosis of dementia, severe visual or dexterity impairment
- 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
- with concomitant disease or concomitant medication that may interfere with treatment or ability to answer questionnaires
- who are unable to self-inject
- who are currently taking or were treated with Byetta® (exenatide) or other GLP-1 agonists within 3 months before screening:
- who are 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 are unwilling or unable to be tested for pregnancy
- with impaired renal function as shown by serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL for females at screening
- 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)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations 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 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013