Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

NCT01195454 | Completed Phase 1

• 2 other identifiers: PKD116272010-020914-27
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: \- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives:

• To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
• To compare the duration of action of a new insulin glargine formulation versus Lantus®
• To explore the dose response and dose exposure relationship of a new insulin glargine formulation
• To assess the safety and tolerability of a new insulin glargine formulation

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)

  36 hours (D1 to D2) in all four treatment periods

Secondary Outcomes (6)

• The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -

  36 hours (D1 to D2) in all four treatment periods

• Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)

  36 hours (D1 to D2) in all four treatment periods

• Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)

  36 hours (D1 to D2) in all four treatment periods

• Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)

  36 hours (D1 to D2) in all four treatment periods

• Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)

  36 hours (D1 to D2) in all four treatment periods

Study Arms (1)

Insulin glargine / New insulin glargine formulation

EXPERIMENTAL

* Period 1: Insulin glargine * Period 2: New insulin glargine formulation * Period 3: New insulin glargine formulation * Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period

Drug: Insulin glargine (HOE901)

Interventions

Insulin glargine (HOE901) DRUG

Pharmaceutical form: Lantus solution for injection Route of administration: subcutaneous

Insulin glargine / New insulin glargine formulation

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 with diabetes mellitus type 1 for more than one year,
• Total insulin dose of \<1.2 U/kg/day,
• Glycohemoglobin (HbA1c) ≤ 9.0%,
• Fasting negative serum C-peptide (\< 0.3 nmol/L),
• Stable insulin regimen for at least 2 months prior to study,
• Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,
• Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.

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,
• 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 SBP 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,
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol,
• Pregnant or breast feeding women,
• Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab),
• Known hypersensitivity to insulin glargine and excipients,
• Any history or presence of deep leg vein thrombosis.
• 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)

Sanofi-Aventis Administrative Office

Berlin, 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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 31, 2011

Record last verified: 2011-10

Locations

DE (1)