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

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)

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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