Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01960179
First received: September 27, 2013
Last updated: May 15, 2014
Last verified: May 2014

September 27, 2013
May 15, 2014
November 2013
March 2015   (final data collection date for primary outcome measure)
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data. [ Time Frame: from baseline to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01960179 on ClinicalTrials.gov Archive Site
  • Absolute change in HbA1c [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]
  • Absolute change in fasting plasma glucose [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]
  • Absolute change in body weight [ Time Frame: from baseline to week 24 and week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Primary Objective:

To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan

Secondary Objective:

To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:

  • HbA1c (Glycated hemoglobin A1c) reduction;
  • Fasting plasma glucose;
  • Body weight.
  • Group 1: 60 weeks ± 11 days
  • Group 2: 32 weeks ± 7 days
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Experimental: lixisenatide
lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment)
Intervention: Drug: lixisenatide AVE0010
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
  • Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
  • Signed written informed consent.

Exclusion criteria:

  • At screening
  • age <20 years;
  • HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%);
  • fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
  • Use of more than one OAD within 3 months prior to screening;
  • Use of Thiazolidinedione (TZD) within 6 months prior to screening;
  • Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
  • Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
  • Type 1 diabetes mellitus
  • Women of childbearing potential with no effective contraceptive method;
  • Pregnancy or lactation;
  • Laboratory findings at the time of screening:

oAmylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);

  • ALT >3 ULN;
  • Calcitonin ≥20 pg/mL (5.9 pmol/L);
  • Positive serum pregnancy test in women of childbearing potential;
  • History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
  • Allergic reaction to metacresol.

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

Both
20 Years and older
No
Contact: For site information, send an email with site number to Contact-Us@sanofi.com
Japan
 
NCT01960179
SFY13476, U1111-1134-2695
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP