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

NCT01349855 | Completed Phase 1

• 2 other identifiers: TDR116262010-023771-26
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory

  up to day 10 of each period

Secondary Outcomes (4)

• Glucose infusion rate

  up to day 10 of each period

• Pharmacokinetic parameter : Cmax

  up to day 10 of each period

• Pharmacokinetic parameter : Tmax

  up to day 10 of each period

• Pharmacokinetic parameter : AUC

  up to day 10 of each period

Study Arms (2)

Cohort 1

EXPERIMENTAL

Dose Level 1

Drug: Insulin glargine HOE901

Cohort 2

EXPERIMENTAL

Dose Level 2

Drug: Insulin glargine HOE901

Interventions

Insulin glargine HOE901 DRUG

Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous

Cohort 1; Cohort 2

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational site number 276001

Neuss, Germany

Location

Related Publications (1)

• Becker RH, Dahmen R, Bergmann K, Lehmann A, Jax T, Heise T. New insulin glargine 300 Units . mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units . mL-1. Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.

  PMID: 25150159 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: May 9, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

DE (1)