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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940965
• Other study ID #: LTS12809
• Secondary ID: U1111-1129-8754
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2013
• Last updated: August 3, 2015
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

54 weeks +/-11 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
• biguanide
Pharmaceutical form:tablet Route of administration: oral
• TZD
Pharmaceutical form:tablet Route of administration: oral
• alpha-GI
Pharmaceutical form:tablet Route of administration: oral
• glinide
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392335	Adachi-Ku
Japan	Investigational Site Number 392325	Chiba-Shi
Japan	Investigational Site Number 392328	Chiyoda-Ku
Japan	Investigational Site Number 392326	Chuo-Ku
Japan	Investigational Site Number 392327	Chuo-Ku
Japan	Investigational Site Number 392310	Chuoh-Ku
Japan	Investigational Site Number 392336	Kagoshima-Shi
Japan	Investigational Site Number 392314	Kamakura-Shi
Japan	Investigational Site Number 392334	Kashiwara-Shi
Japan	Investigational Site Number 392304	Kawagoe-Shi
Japan	Investigational Site Number 392306	Kawaguchi-Shi
Japan	Investigational Site Number 392307	Kisarazu-Shi
Japan	Investigational Site Number 392301	Koriyama-Shi
Japan	Investigational Site Number 392312	Mitaka-Shi
Japan	Investigational Site Number 392302	Mito-Shi
Japan	Investigational Site Number 392324	Mito-Shi
Japan	Investigational Site Number 392331	Nagoya-Shi
Japan	Investigational Site Number 392332	Nagoya-Shi
Japan	Investigational Site Number 392329	Ohta-Ku
Japan	Investigational Site Number 392322	Okawa-Shi
Japan	Investigational Site Number 392333	Osaka-Shi
Japan	Investigational Site Number 392330	Sagamihara-Shi
Japan	Investigational Site Number 392320	Saijo-Shi
Japan	Investigational Site Number 392303	Sakado-Shi
Japan	Investigational Site Number 392311	Shinjuku-Ku
Japan	Investigational Site Number 392316	Shizuoka-Shi
Japan	Investigational Site Number 392319	Suita-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data		52 weeks	Yes
Secondary	Absolute change in HbA1c		From baseline to weeks 24 and 52	No
Secondary	Absolute change in fasting plasma glucose		From baseline to weeks 24 and 52	No
Secondary	Absolute change in body weight		From baseline to weeks 24 and 52	No