Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy (EDITION II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01499095
First received: December 16, 2011
Last updated: May 7, 2014
Last verified: May 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 Objective:

- 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: Lantus (Insulin glargine)
Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Oral Antidiabetics
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 in Combination With Oral Antihyperglycemic Drug(s) 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: No ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]

Enrollment: 811
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of insulin glargine
once daily on top of oral antidiabetic drugs
Drug: HOE901-U300 (new formulation of insulin glargine)

Pharmaceutical form:solution

Route of administration: subcutaneous

Drug: Oral Antidiabetics
Patients are enrolled with an oral antihyperglycemic background therapy taken at a stable dose for at least 3 months prior to the screening visit. The doses and combinations used are to be according to the authorized local labeling. Doses should be kept stable throughout the study.
Active Comparator: Lantus (insulin glargine)
once daily on top of oral antidiabetic drugs
Drug: Lantus (Insulin glargine)

Pharmaceutical form:solution

Route of administration: subcutaneous

Other Name: Lantus
Drug: Oral Antidiabetics
Patients are enrolled with an oral antihyperglycemic background therapy taken at a stable dose for at least 3 months prior to the screening visit. The doses and combinations used are to be according to the authorized local labeling. Doses should be kept stable throughout the study.

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 :

o 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 6 months on basal insulin treatment together with oral antihyperglycemic drugs and self-monitoring of blood glucose;
  • Patients using sulfonylurea in the last 2 months before screening visit;
  • Any contraindication to use of insulin glargine as defined in the national product label;
  • Use of insulin pump in the last 6 months before screening;
  • Initiation of new glucose-lowering medications 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:

o 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
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: NCT01499095

  Show 213 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01499095     History of Changes
Other Study ID Numbers: EFC11629, 2010-023770-39, U1111-1118-6943
Study First Received: December 16, 2011
Last Updated: May 7, 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 22, 2014