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
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin glargine new formulation (HOE901)
Drug: Insulin glargine (HOE901)
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® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs With a 6-month Safety Extension Period

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 881
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine - new formulation
once daily on top of non-insulin antihyperglycemic drugs
Drug: Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Active Comparator: Lantus (Insulin glargine)
once daily on top of non-insulin antihyperglycemic drugs
Drug: Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Name: Lantus

Detailed Description:

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.
  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676220

  Show 224 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676220     History of Changes
Other Study ID Numbers: EFC12347, 2012-000146-35, U1111-1124-5261
Study First Received: August 28, 2012
Last Updated: April 10, 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
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014