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Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01053728
First received: January 19, 2010
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

Primary Objective:

- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.

Secondary Objective:

- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: SAR161271
Drug: Insulin glargine HOE901
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • - Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort [ Time Frame: up to 7 days after dose ] [ Designated as safety issue: Yes ]
  • - Pharmacodynamics (Glucose infusion rate) time-action profile [ Time Frame: up to 30 hours after dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Pharmacokinetic parameters [ Time Frame: up to 168 hours after dose ] [ Designated as safety issue: No ]
  • - anti-insulin antibody production [ Time Frame: pre-dose and after 4th dose ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 : SAR161271 0.3 U/kg
Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
 Drug: SAR161271

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Drug: Insulin glargine HOE901

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous
Experimental: Cohort 2 : SAR161271 0.6 U/kg
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
 Drug: SAR161271

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Drug: Insulin glargine HOE901

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous
Experimental: Cohort 3 : SAR161271 1.2 U/kg
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
 Drug: SAR161271

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Drug: Insulin glargine HOE901

Pharmaceutical form:Solution for injection

Route of administration: subcutaneous

Detailed Description:

The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:

  • Screening: 3 to 27 days;
  • Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;
  • Wash-out between doses: 7 to 10 days;
  • End of Study visit: 7 to 10 days after last dose.
  • Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients who have type 1 diabetes mellitus (T1DM) as defined by American Diabetes Association average total insulin dose of <1.2 U/kg/day
  • Fasting negative serum C-peptide (<0.3 nmol/L)
  • Glycated hemoglobin (HbA1c) < or = 9%
  • Stable insulin regimen for at least 2 months before the study
  • Body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive
  • Certified as healthy for T1DM by a comprehensive clinical assessment

Exclusion criteria:

  • Any history or presence of clinically relevant (for T1DM) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy.
  • Blood donation, any volume, within 1 month before inclusion.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
  • Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs
  • Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053728

Locations
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01053728     History of Changes
Other Study ID Numbers: TDU10987, TDU10948
Study First Received: January 19, 2010
Last Updated: July 25, 2011
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013