Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01658579
First received: July 26, 2012
Last updated: April 8, 2014
Last verified: April 2014

July 26, 2012
April 8, 2014
July 2012
May 2013   (final data collection date for primary outcome measure)
Percent (%) of time in target plasma glucose range (80-140mg/dL) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Percent (%) of time in target plasma glucose range [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01658579 on ClinicalTrials.gov Archive Site
  • Percent time above the upper limit (> 140 mg/dL; i.e. > 7.8 mmol/L) of glycemic range [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Percent time below the lower limit (< 80 mg/dL; i.e. < 4.4 mmol/L) of glycemic range [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Evaluation of diurnal glucose exposure, variability, and stability [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Average time within glycemic range >80 mg/dL (4.4 mmol/L) and ≤140 mg/dL (7.8 mmol/L) in the last four hours of each dosing interval [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c from baseline to endpoint [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) from baseline to endpoint [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in 7-point self-monitored plasma glucose (SMPG) per timepoint from baseline to endpoint [ Time Frame: from baseline to 16 week ] [ Designated as safety issue: No ]
  • Change in daily basal insulin dose from baseline to endpoint [ Time Frame: from baseline to 16 week ] [ Designated as safety issue: No ]
  • Number of Patients with various types of Hypoglycemia Events [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Change in 7-point self-monitored plasma glucose [ Time Frame: from baseline to 16 weeks ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: Up to 16 weeks ] [ 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 on Basal Plus Mealtime Insulin
A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus

Primary Objective:

- To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult patients with type 1 diabetes mellitus

Secondary Objectives:

  • To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
  • To compare the incidence and frequency of hypoglycemic episodes
  • To assess the safety and tolerability of the new formulation of insulin glargine
  • Up to 4-week screening period;
  • 16-week open-label comparative efficacy and safety treatment period;
  • 4-week post-treatment safety follow-up period.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: HOE901-U300 (new formulation of insulin glargine)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Drug: Lantus (insulin glargine)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Experimental: H0E901-U300 Morning then Evening
    Treatment period A (8 weeks): morning injection followed by Treatment period B (8 weeks): evening injection
    Intervention: Drug: HOE901-U300 (new formulation of insulin glargine)
  • Active Comparator: Lantus Morning then Evening
    Intervention: Drug: Lantus (insulin glargine)
  • Experimental: HOE901-U300 Evening then Morning
    Intervention: Drug: HOE901-U300 (new formulation of insulin glargine)
  • Active Comparator: Lantus Evening then Morning
    Intervention: Drug: Lantus (insulin glargine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria :

  • Patients with type 1 diabetes mellitus

Exclusion criteria:

  • HbA1c >9% (at screening);
  • Patients receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit;
  • Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
  • Less than 1 year on any basal plus mealtime insulin;
  • Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic 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;
  • Any contraindication to use of insulin glargine as defined in the national product label;
  • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
  • Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization;
  • Initiation of any glucose-lowering agents in the last 3 months before screening visit;
  • Weight change of ≥5 kg during the last 3 months prior to screening visit;
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require 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 to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01658579
PDY12777, U1111-1130-3593
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