Text Size

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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01676220
First received: August 28, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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 Objective:

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of nocturnal hypoglycemia


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:

U.S. FDA Resources

Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 800
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 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
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 5, 2013
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 May 16, 2013