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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

September 7, 2012
April 10, 2014
September 2012
September 2013   (final data collection date for primary outcome measure)
Change from baseline in HbA1c [ 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 NCT01683266 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in Pre-injection plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in Fasting plasma glucose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change in 8-point self-monitored plasma glucose profile [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: 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 1 Diabetes Mellitus
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

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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 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: New formulation of insulin glargin - Morning
    once daily in the morning on-top of mealtime insulin
    Intervention: Drug: Insulin glargine new formulation (HOE901)
  • Active Comparator: Lantus (insulin glargine) - Morning
    once daily in the morning on-top of mealtime insulin
    Intervention: Drug: Insulin glargine (HOE901)
  • Experimental: New formulation of insulin glargin - Evening
    once daily in the evening on-top of mealtime insulin
    Intervention: Drug: Insulin glargine new formulation (HOE901)
  • Active Comparator: Lantus (insulin glargine) - Evening
    once daily in the evening on-top of mealtime insulin
    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
551
March 2014
September 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Denmark,   Estonia,   Finland,   Hungary,   Japan,   Latvia,   Netherlands,   Puerto Rico,   Romania,   Sweden
 
NCT01683266
EFC12456, 2012-001524-35, U1111-1128-5517
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