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
  Purpose

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

Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: HOE901-U300 (new formulation of insulin glargine)
Drug: Lantus (insulin glargine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent (%) of time in target plasma glucose range (80-140mg/dL) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H0E901-U300 Morning then Evening
Treatment period A (8 weeks): morning injection followed by Treatment period B (8 weeks): evening injection
Drug: HOE901-U300 (new formulation of insulin glargine)

Pharmaceutical form: solution

Route of administration: subcutaneous

Active Comparator: Lantus Morning then Evening Drug: Lantus (insulin glargine)

Pharmaceutical form: solution

Route of administration: subcutaneous

Experimental: HOE901-U300 Evening then Morning Drug: HOE901-U300 (new formulation of insulin glargine)

Pharmaceutical form: solution

Route of administration: subcutaneous

Active Comparator: Lantus Evening then Morning Drug: Lantus (insulin glargine)

Pharmaceutical form: solution

Route of administration: subcutaneous


Detailed Description:
  • Up to 4-week screening period;
  • 16-week open-label comparative efficacy and safety treatment period;
  • 4-week post-treatment safety follow-up period.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01658579

Locations
United States, California
Investigational Site Number 840002
Temecula, California, United States, 92591
United States, Minnesota
Investigational Site Number 840001
Minneapolis, Minnesota, United States, 55416
United States, Oregon
Investigational Site Number 840003
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01658579     History of Changes
Other Study ID Numbers: PDY12777, U1111-1130-3593
Study First Received: July 26, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014