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

Study Overview
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Brief Summary
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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.

Detailed Description
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54 weeks +/-11 days

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: lixisenatide AVE0010
* Drug: biguanide
* Drug: TZD
* Drug: alpha-GI
* Drug: glinide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lixisenatide + Biguanide<br>52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label) | Drug: lixisenatide AVE0010<br>* Pharmaceutical form:solution Route of administration: Subcutaneous injection<br>Drug: biguanide<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Experimental: Lixisenatide + TZD<br>52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label) | Drug: lixisenatide AVE0010<br>* Pharmaceutical form:solution Route of administration: Subcutaneous injection<br>Drug: TZD<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Experimental: Lixisenatide + alpha-GI<br>52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label) | Drug: lixisenatide AVE0010<br>* Pharmaceutical form:solution Route of administration: Subcutaneous injection<br>Drug: alpha-GI<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Experimental: Lixisenatide + Glinide<br>52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label) | Drug: lixisenatide AVE0010<br>* Pharmaceutical form:solution Route of administration: Subcutaneous injection<br>Drug: glinide<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in HbA1c |  | From baseline to weeks 24 and 52 | 
| Absolute change in fasting plasma glucose |  | From baseline to weeks 24 and 52 | 
| Absolute change in body weight |  | From baseline to weeks 24 and 52 |