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Completed

NCT Number: NCT01676233

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 392001

Kumamoto, Japan

About this study

66 days

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin glargine (HOE901)

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

insulin glargine- new formulation (HOE901)

Drug

Pharmaceutical form: solution Route of administration: subcutaneous

Primary outcomes

  1. Change in 24-hour blood glucose profile measured by continuous glucose monitoring

    Time frame: Baseline, Day 28, Day 56

Secondary outcomes

  1. Hypoglycemia categorized by the definition of American Diabetes Association

    Time frame: Up to Day 56

  2. Change in fasting plasma glucose from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

  3. Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

  4. Change in HbA1c from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2012
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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