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

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. Identifier: NCT01349855
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : June 1, 2011
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Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin glargine HOE901 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Glucose infusion rate [ Time Frame: up to day 10 of each period ]
  2. Pharmacokinetic parameter : Cmax [ Time Frame: up to day 10 of each period ]
  3. Pharmacokinetic parameter : Tmax [ Time Frame: up to day 10 of each period ]
  4. Pharmacokinetic parameter : AUC [ Time Frame: up to day 10 of each period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01349855

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Investigational site number 276001
Neuss, Germany
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT01349855    
Other Study ID Numbers: TDR11626
2010-023771-26 ( EudraCT Number )
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs