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

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: glinide
Drug: biguanide
Drug: alpha-GI
Drug: TZD
Drug: lixisenatide AVE0010

Study type

Interventional

Funder types

Industry

Identifiers

NCT01940965
LTS12809
U1111-1129-8754 (Other Identifier)

Details and patient eligibility

About

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.

Full description

54 weeks +/-11 days

Enrollment

294 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

294 participants in 4 patient groups

Lixisenatide + Biguanide
Experimental group
Description:
52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Treatment:
Drug: biguanide
Drug: lixisenatide AVE0010
Lixisenatide + TZD
Experimental group
Description:
52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Treatment:
Drug: lixisenatide AVE0010
Drug: TZD
Lixisenatide + alpha-GI
Experimental group
Description:
52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Treatment:
Drug: alpha-GI
Drug: lixisenatide AVE0010
Lixisenatide + Glinide
Experimental group
Description:
52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Treatment:
Drug: glinide
Drug: lixisenatide AVE0010

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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