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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01683266
First received: September 7, 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 (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled month 6) in patients with type 1 diabetes mellitus

Secondary Objective:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile


Condition Intervention Phase
Type 1 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: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 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:
  • Proportion (%) of patients with HbA1c <7 % [ Time Frame: 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 from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with fasting plasma glucose <80 mg/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in 8-point self-monitored plasma glucose profiles per time-point from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in pre-basal insulin injection plasma glucose from baseline to endpoint [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in daily 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: No ]

Enrollment: 551
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New formulation of insulin glargin - Morning
once daily in the morning on-top of mealtime insulin
Drug: Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine) - Morning
once daily in the morning on-top of mealtime insulin
Drug: Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Name: Lantus
Experimental: New formulation of insulin glargin - Evening
once daily in the evening on-top of mealtime insulin
Drug: Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine) - Evening
once daily in the evening on-top of mealtime insulin
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:

  • Up to 2-week screening period;
  • 6-month open-label comparative efficacy and safety treatment period;
  • 6-month open-label comparative safety extension period;
  • 48-hour 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 1 diabetes mellitus

Exclusion criteria:

HbA1c <7.0% (53 mmol/mol) or >10% (86 mmol/mol) at screening;

Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit;

Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;

Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit;

Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months;

Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;

Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;

Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, 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: NCT01683266

  Show 160 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01683266     History of Changes
Other Study ID Numbers: EFC12456, 2012-001524-35, U1111-1128-5517
Study First Received: September 7, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014