Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01676220
First received: August 28, 2012
Last updated: April 10, 2014
Last verified: April 2014

August 28, 2012
April 10, 2014
August 2012
October 2013   (final data collection date for primary outcome measure)
Change in HbA1c from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
Change in HbA1c [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01676220 on ClinicalTrials.gov Archive Site
  • Incidence (%) of patients with at least one nocturnal hypoglycemia, indicated as severe and/or confirmed by plasma glucose ≤ 70 mg/dL(3.9 mmol/L) occurred from week9 to endpoint [ Time Frame: week 9, 6 months ] [ Designated as safety issue: No ]
  • Change in pre-injection plasma glucose from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in variability of pre-injection plasma glucose (coefficient of variation over 7 days) from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with HbA1c <7 % at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with FPG <100 mg/dL [ Time Frame: 12 weeks, 6 month ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in 8-point SMPG profiles per time-point from baseline to endpoint [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Change of mean 24h plasma glucose (based on 8-point SMPG profiles) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in variability in mean 24h plasma glucose (based on 8-point SMPG profiles) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in daily basal insulin dose from baseline to endpoint [ 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: No ]
  • Number of Patients with various types of Hypoglycemia Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
  • Hypoglycemia [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • 8-point self-monitored plasma glucose profile [ Time Frame: baseline, 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 on Non-insulin Antidiabetic Therapy
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6, week 26) in patients with type 2 diabetes mellitus.

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

  • occurrence of nocturnal hypoglycemia
  • change in pre-injection plasma glucose,
  • change in variability of pre-injection plasma glucose

The maximum study duration will be 54 weeks per patient, consisting of:

  • up to 2 week screening period; it can be exceptionally extended of up to one additional week;
  • 6-month comparative efficacy and safety treatment period;
  • 6-month comparative safety extension period;
  • 2-day post-treatment safety follow-up period.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Insulin glargine new formulation (HOE901)
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Drug: Insulin glargine (HOE901)
    Pharmaceutical form: solution Route of administration: subcutaneous
    Other Name: Lantus
  • Experimental: Insulin glargine - new formulation
    once daily on top of non-insulin antihyperglycemic drugs
    Intervention: Drug: Insulin glargine new formulation (HOE901)
  • Active Comparator: Lantus (Insulin glargine)
    once daily on top of non-insulin antihyperglycemic drugs
    Intervention: Drug: Insulin glargine (HOE901)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
881
March 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion criteria :

  • Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
  • Signed written informed consent.

Exclusion criteria:

  • HbA1c < 7.0% (< 53 mmol/mol) or > 11% (> 97 mmol/mol) [at screening];
  • History of type 2 diabetes mellitus for less than 1 year before screening;
  • Less than 6 months before screening with non-insulin antihyperglycemic treatment;
  • Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening;
  • Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of GLP-1 receptor agonist in the last 6 months before screening visit;
  • Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline);
  • Current or previous insulin use except for a maximum of 8 consecutive days (e.g. acute illness, surgery) during the last year prior to screening;
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g. laser, surgical treatment or injectable drugs) during the study period.

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
Bulgaria,   Canada,   Czech Republic,   Denmark,   Estonia,   Finland,   Hungary,   Japan,   Latvia,   Lithuania,   Netherlands,   Romania,   Slovakia,   Sweden,   United States,   Puerto Rico
 
NCT01676220
EFC12347, 2012-000146-35, U1111-1124-5261
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
April 2014

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