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Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus

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ClinicalTrials.gov Identifier: NCT02201199
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

Secondary Objectives:

To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: insulin glargine U200 HOE901 Drug: insulin glargine U500 HOE901 Drug: insulin glargine U100 HOE901 Phase 1

Detailed Description:

Total study duration for each subject is between 3.5 and 12 weeks.

Two overnight stays at the unit in each of 3 treatment periods.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes
Study Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: insulin glargine U100
1 single dose
Drug: insulin glargine U100 HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other Name: Lantus

Experimental: insulin glargine U200
1 single dose
Drug: insulin glargine U200 HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Experimental: insulin glargine U500
1 single dose
Drug: insulin glargine U500 HOE901
Pharmaceutical form:solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36) [ Time Frame: 36 hours ]
  2. AUC up to the last measurable concentration [ Time Frame: 36 hours ]
  3. Time to reach 50% of INS-AUC 0-36 [ Time Frame: 36 hours ]
  4. Time to reach INS-Cmax (INS-tmax) [ Time Frame: 36 hours ]
  5. Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36) [ Time Frame: 36 hours ]
  6. Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36) [ Time Frame: 36 hours ]
  7. Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax) [ Time Frame: 36 hours ]
  8. Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels) [ Time Frame: 4 days ]
  9. Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters) [ Time Frame: 4 days ]


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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
Criteria

Inclusion criteria:

  • Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association.
  • Total insulin dose <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.
  • Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.
  • Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

  • 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).
  • Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment.
  • Presence or history of drug or alcohol abuse (alcohol consumption >40 grams / day).
  • Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.
  • Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication in the last month before study start with the exception of insulin products, 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; any biologics (antibody or its derivatives) given within 4 months before randomization.
  • 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): NCT02201199


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: NCT02201199     History of Changes
Other Study ID Numbers: PDY13928
2014-001252-33
U1111-1153-3712 ( Other Identifier: UTN )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

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