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Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01676233
First Posted: August 30, 2012
Last Update Posted: August 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state

Secondary Objectives:

  • To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
  • To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
  • To compare the occurrence of hypoglycemia between the 2 treatments;
  • To assess the safety and tolerability of a new formulation of insulin glargine.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in 24-hour blood glucose profile measured by continuous glucose monitoring [ Time Frame: Baseline, Day 28, Day 56 ]

Secondary Outcome Measures:
  • Hypoglycemia categorized by the definition of American Diabetes Association [ Time Frame: Up to Day 56 ]
  • Change in fasting plasma glucose from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ]
  • Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ]
  • Change in HbA1c from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ]

Enrollment: 20
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Drug: insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Drug: insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Experimental: Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Drug: insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Drug: insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous

Detailed Description:
66 days
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;

Exclusion criteria:

  • Age < 20 years at written informed consent;
  • HbA1c < 6.5% or > 10.0% at screening
  • Diabetes mellitus (DM) other than T1DM;
  • Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
  • Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
  • Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676233


Locations
Japan
Investigational Site Number 392001
Kumamoto-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676233     History of Changes
Other Study ID Numbers: PDY12335
U1111-1129-3633 ( Other Identifier: UTN )
First Submitted: August 28, 2012
First Posted: August 30, 2012
Last Update Posted: August 19, 2013
Last Verified: August 2013

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
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs