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

NCT02201199 | Completed Phase 1

• 3 other identifiers: PDY139282014-001252-33U1111-1153-3712
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing

  12 hours

Secondary Outcomes (9)

• INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)

  36 hours

• AUC up to the last measurable concentration

  36 hours

• Time to reach 50% of INS-AUC 0-36

  36 hours

• Time to reach INS-Cmax (INS-tmax)

  36 hours

• 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)

  36 hours

Study Arms (3)

insulin glargine U100

ACTIVE COMPARATOR

1 single dose

Drug: insulin glargine U100 HOE901

insulin glargine U200

EXPERIMENTAL

1 single dose

Drug: insulin glargine U200 HOE901

insulin glargine U500

EXPERIMENTAL

1 single dose

Drug: insulin glargine U500 HOE901

Interventions

insulin glargine U200 HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

insulin glargine U200

insulin glargine U500 HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

insulin glargine U500

insulin glargine U100 HOE901 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Also known as: Lantus

insulin glargine U100

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 276001

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

DE (1)