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Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01349855
First received: April 15, 2011
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  Purpose

Primary Objective:

To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen

Secondary Objective:

To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: Insulin glargine HOE901
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus® in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory [ Time Frame: up to day 10 of each period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Glucose infusion rate [ Time Frame: up to day 10 of each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter : Cmax [ Time Frame: up to day 10 of each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter : Tmax [ Time Frame: up to day 10 of each period ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter : AUC [ Time Frame: up to day 10 of each period ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose Level 1
 Drug: Insulin glargine HOE901
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
Experimental: Cohort 2
Dose Level 2
 Drug: Insulin glargine HOE901
Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous

Detailed Description:

The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes mellitus type 1 for more than one year, as defined by the American Diabetes Association
  • Body weight between 50.0 kg and 110.0 kg,
  • Body Mass Index between 18.0 and 30.0 kg/m2 inclusive
  • Stable insulin regimen for at least 2 months prior to study
  • Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination
  • Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm; cervical/vault cap; 3) spermicide.

Exclusion criteria:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
  • More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
  • Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
  • Participation in a trial with any investigational drug during the past three months
  • Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study
  • Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days
  • Known hypersensitivity to insulin glargine or excipients of the study drug
  • Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children)

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: NCT01349855

Locations
Germany
Investigational site number 276001
Neuss, Germany
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01349855     History of Changes
Other Study ID Numbers: TDR11626, 2010-023771-26
Study First Received: April 15, 2011
Last Updated: May 31, 2011
Health Authority: Germany: Ethics Commission

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 17, 2013