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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 is currently recruiting participants.
Verified February 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01676233
First received: August 28, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycemia categorized by the definition of American Diabetes Association [ Time Frame: Up to Day 56 ] [ Designated as safety issue: Yes ]
  • Change in fasting plasma glucose from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ] [ Designated as safety issue: No ]
  • Change in HbA1c from baseline to each treatment end by treatment [ Time Frame: Baseline, Day 28, Day 56 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676233

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01676233     History of Changes
Other Study ID Numbers: PDY12335, U1111-1129-3633
Study First Received: August 28, 2012
Last Updated: February 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on June 18, 2013