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

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ClinicalTrials.gov Identifier: NCT01053728
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: SAR161271 Drug: Insulin glargine HOE901 Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : February 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. - 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 ]
  2. - Pharmacodynamics (Glucose infusion rate) time-action profile [ Time Frame: up to 30 hours after dose ]

Secondary Outcome Measures :
  1. - Pharmacokinetic parameters [ Time Frame: up to 168 hours after dose ]
  2. - anti-insulin antibody production [ Time Frame: pre-dose and after 4th dose ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053728


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

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01053728     History of Changes
Other Study ID Numbers: TDU10987
TDU10948
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs