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

NCT01226043 | Completed Phase 4 Results

• 2 other identifiers: LANTU_L_05191U1111-1116-3054
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• Patient Preference Composite Score

  At week 4 (end of crossover phase)

• Healthcare Professional's (HCP) Recommendation

  At week 4 (end of crossover phase)

• Change in Fasting Plasma Glucose (FPG)

  From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)

• Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL

  At week 10 (end of re-randomization phase)

• Change in Lantus Dose Injected Per Day

  From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)

Other Outcomes (1)

• Number of Patients With Hypoglycemic Events

  each study phase (crossover, re-randomization, observational) up to 40 weeks

Study Arms (2)

Lantus (insulin glargine) vial & syringe

EXPERIMENTAL

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

Lantus (insulin glargine) SoloSTAR pen

EXPERIMENTAL

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

Interventions

Insulin Glargine DRUG

* Pharmaceutical form: solution for injection * Route of administration: subcutaneous

Also known as: Lantus

Lantus (insulin glargine) SoloSTAR pen; Lantus (insulin glargine) vial & syringe

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 21, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 12, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-07

Locations

US (1)