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: August 12, 2014
Last verified: August 2014

December 16, 2011
August 12, 2014
December 2011
January 2013   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Change in HbA1c [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01499082 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 8-point self-monitored plasma glucose profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
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

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: HOE901-U300 (new formulation of insulin glargine)
    Pharmaceutical form:solution Route of administration: subcutaneous
  • Drug: Lantus (insulin glargine)
    Pharmaceutical form:solution Route of administration: subcutaneous
    Other Name: Lantus
  • Experimental: New formulation of insulin glargine
    once daily on top of mealtime insulin with or without metformin
    Intervention: Drug: HOE901-U300 (new formulation of insulin glargine)
  • Active Comparator: Lantus (insulin glargine)
    once daily on top of mealtime insulin with or without metformin
    Intervention: Drug: Lantus (insulin glargine)
Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; on behalf of the EDITION 1 Study Investigators. New Insulin Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 2 Diabetes Using Basal and Mealtime Insulin: Glucose Control and Hypoglycemia in a 6-Month Randomized Controlled Trial (EDITION 1). Diabetes Care. 2014 Jul 30. pii: DC_140991. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
807
September 2013
January 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Hungary,   Latvia,   Mexico,   Netherlands,   Romania,   South Africa,   United States
 
NCT01499082
EFC11628, 2010-023769-23
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP