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

NCT01838083 | Completed Phase 1

• 3 other identifiers: PKD135602012-005777-31U1111-1139-3755
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Type1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6

  24-hours (D6 to D7)

Secondary Outcomes (9)

• Maximum insulin concentration (INS-Cmax)

  24-hours (D6 to D7)

• Time to INS-Cmax (INS-tmax)

  24-hours (D6 to D7)

• Time to reach 50% of INS-AUC0-24 (T50%-INS-AUC0-24)

  24-hours (D6 to D7)

• Area under the body-weight-standardized Glucose Infusion Rate (GIR) within 24 hours (GIR-AUC0-24h) after dosing on Day 6 during the clamp

  24-hours (D6 to D7)

• Maximum smoothed body weight standardized glucose infusion rate (GIRmax)

  24-hours (D6 to D7)

Study Arms (2)

Insulin glargine new formulation (test T formulation)

EXPERIMENTAL

Once daily for 6 days

Drug: Insulin glargine new formulation HOE901

Insulin glargine new formulation (reference R formulation)

EXPERIMENTAL

Once daily for 6 days

Drug: Insulin glargine new formulation HOE901

Interventions

Insulin glargine new formulation HOE901 DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Insulin glargine new formulation (reference R formulation); Insulin glargine new formulation (test T formulation)

Eligibility Criteria

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

You may qualify if:

• 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 \[≤ 9.0%\]
• 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

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 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 276001

Neuss, 41460, Germany

Location

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: April 16, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

DE (1)