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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Biguanides; Hypoglycemic Agents; Lixisenatide

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.