Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01940965
First received: September 9, 2013
Last updated: August 14, 2014
Last verified: August 2014

September 9, 2013
August 14, 2014
September 2013
August 2015   (final data collection date for primary outcome measure)
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01940965 on ClinicalTrials.gov Archive Site
  • Absolute change in HbA1c [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]
  • Absolute change in fasting plasma glucose [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]
  • Absolute change in body weight [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
An Open-Label, Multicenter 52-Week Study Assessing the Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Primary Objective:

The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective:

To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:

  • HbA1c;
  • Fasting plasma glucose;
  • Body weight.

54 weeks +/-11 days

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: lixisenatide AVE0010
    Pharmaceutical form:solution Route of administration: Subcutaneous injection
  • Drug: biguanide
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: TZD
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: alpha-GI
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: glinide
    Pharmaceutical form:tablet Route of administration: oral
  • Experimental: Lixisenatide + Biguanide
    52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: biguanide
  • Experimental: Lixisenatide + TZD
    52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: TZD
  • Experimental: Lixisenatide + alpha-GI
    52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: alpha-GI
  • Experimental: Lixisenatide + Glinide
    52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: glinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
292
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion criteria :

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year before the screening visit
  • Patient treated for at least 3 months prior to screening visit with one of following OADs at a stable dose of at least usual maintenance dose as described in the label

    • a biguanide (metformin hydrochloride);
    • a thiazolidinedione (TZD) (pioglitazone hydrochloride);
    • an alpha-glucosidase inhibitor (alpha-GI) (acarbose, voglibose or miglitol);
    • or a glinide (nateglinide, repaglinide or mitiglinide);
  • Signed written informed consent

Exclusion criteria:

  • At screening HbA1c <7% or >9.5%;
  • At screening: fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
  • Use of any glucose-lowering agent(s) other than the authorized patient's background treatment defined in I02 (as given in inclusion critieria) within 3 months prior to screening;
  • Type 1 diabetes mellitus;
  • Women of childbearing potential with no effective contraceptive method;
  • Pregnancy or lactation;
  • Laboratory findings at the time of screening:

    • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);
    • ALT >3 ULN;
  • Any contra-indication to the patient's background oral anti-diabetic treatment;
  • 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);
  • Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP1 receptor agonist.

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
Yes
Contact: For site information, send an email with site number to Contact-Us@sanofi.com
Japan
 
NCT01940965
LTS12809, U1111-1129-8754
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

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