Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499082
First received: December 16, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

Primary Objective:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of Change in HbA1c from baseline to endpoint (scheduled month 6)

Secondary Objectives:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of Hypoglycemia


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Lantus (insulin glargine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose <= 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in variability of preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with HbA1c < 7% at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with FPG < 100mg/dL at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point self-monitored plasma glucose profile [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in daily basal insulin dose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 807
Study Start Date: December 2011
Study Completion Date: September 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of insulin glargine
once daily on top of mealtime insulin with or without metformin
Drug: HOE901-U300 (new formulation of insulin glargine)
Pharmaceutical form:solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine)
once daily on top of mealtime insulin with or without metformin
Drug: Lantus (insulin glargine)
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus

Detailed Description:

The maximum study duration will be 58 weeks per patient, consisting of:

  • up to 2 week screening period;
  • 6-month comparative efficacy and safety treatment period;
  • 6-month comparative safety extension period;
  • 4-week safety follow-up period.
  • a 3-month administration substudy period starting after completion of the 6-month study period for patients willing to.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with type 2 diabetes mellitus
  • Substudy inclusion criteria:

    • Completion of the 6-month study period in main study (Visit 10)
    • Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

  • Age <18 years;
  • HbA1c <7.0% or >10% at screening;
  • Diabetes other than type 2 diabetes mellitus;
  • Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
  • Any contraindication to use of insulin glargine as defined in the national product label;
  • Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
  • Use of an insulin pump in the last 6 months before screening visit;
  • Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit;
  • History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study period
  • Substudy exclusion criteria:

    • Patient not willing to use the adaptable injection intervals on at least two days per week.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499082

  Show 193 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01499082     History of Changes
Other Study ID Numbers: EFC11628, 2010-023769-23
Study First Received: December 16, 2011
Last Updated: February 13, 2014
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 April 16, 2014