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Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01838083
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate equivalence in exposure to insulin glargine given as test formulation T and reference formulation R in steady state conditions after 6 once-daily subcutaneous (SC) doses

Secondary Objective:

  • To assess relative Pharmacodynamic activity of the insulin glargine test formulation T to the insulin glargine reference formulation R in steady state conditions after 6 once-daily SC doses
  • To assess the safety and tolerability of the test and reference formulations of two new insulin glargine formulations

Condition or disease Intervention/treatment Phase
Type1 Diabetes Drug: Insulin glargine new formulation HOE901 Phase 1

Detailed Description:

Total study duration per subject: 29 to 64 days including screening visit

Duration of each part of the study for one subject:

  • Screening: 3 to 21 days before 1st dosing (Day -21 to Day -3)
  • Treatment Period 1 and 2: 8 days (dosing on 6 days)
  • Washout between last/1st dosing days of the treatment periods: 7-21 days (preferentially 7 days) End-of-Study Visit: 7-10 days after last dosing

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two New Insulin Glargine Formulations Using the Euglycemic Clamp Technique in Subjects With Type 1 Diabetes Mellitus
Study Start Date : April 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin glargine new formulation (test T formulation)
Once daily for 6 days
Drug: Insulin glargine new formulation HOE901
Pharmaceutical form: solution Route of administration: subcutaneous

Experimental: Insulin glargine new formulation (reference R formulation)
Once daily for 6 days
Drug: Insulin glargine new formulation HOE901
Pharmaceutical form: solution Route of administration: subcutaneous




Primary Outcome Measures :
  1. Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6 [ Time Frame: 24-hours (D6 to D7) ]

Secondary Outcome Measures :
  1. Maximum insulin concentration (INS-Cmax) [ Time Frame: 24-hours (D6 to D7) ]
  2. Time to INS-Cmax (INS-tmax) [ Time Frame: 24-hours (D6 to D7) ]
  3. Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24) [ Time Frame: 24-hours (D6 to D7) ]
  4. Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp [ Time Frame: 24-hours (D6 to D7) ]
  5. Maximum smoothed body weight standardized glucose infusion rate (GIRmax) [ Time Frame: 24-hours (D6 to D7) ]
  6. Time to GIRmax (GIR-Tmax) [ Time Frame: 24-hours (D6 to D7) ]
  7. Time to reach at least 50% of GIR-AUC0-24 (T50%-GIR-AUC0-24) [ Time Frame: 24-hours (D6 to D7) ]
  8. Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different prespecified blood glucose levels) [ Time Frame: 24-hours (D6 to D7) ]
  9. Safety as measured by adverse events/serious adverse events, ohypoglycemia events, physical examinations, clinical laboratory, electrocardiograms, vital signs, injection site reactions and anti-insulin antibodies. [ Time Frame: up to 9 weeks ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
  • Total insulin dose of < 1.2 U/kg/day
  • Minimum usual basal insulin dose ≥ 0.2 U/kg/day
  • Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
  • Fasting negative serum C-peptide (< 0.3 nmol/L)
  • Glycohemoglobin (HbA1c) ≤ 75 mmol/mol [≤ 9.0%]
  • Stable insulin regimen for at least 2 months prior to inclusion in study
  • Certified as otherwise healthy for Type-1 Diabetes mellitus patient
  • Laboratory parameters within the normal range
  • Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status

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
  • Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month)
  • Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
  • Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Presence or history of drug or alcohol abuse (alcohol consumption > 40 grams / day)
  • If female, pregnancy (defined as positive Beta Human Chorionic Gonadotropin test), breast-feeding
  • 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 ClinicalTrials.gov identifier (NCT number): NCT01838083


Locations
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Germany
Investigational Site Number 276001
Neuss, Germany, 41460
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01838083     History of Changes
Other Study ID Numbers: PKD13560
2012-005777-31 ( EudraCT Number )
U1111-1139-3755 ( Other Identifier: UTN )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

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
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs