Clinical trial NCT01940965: Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 294
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 54 weeks +/-11 days

Eligibility 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.

Primary outcomes:
measure: Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data
timeFrame: 52 weeks
Secondary outcomes:
measure: Absolute change in HbA1c
timeFrame: From baseline to weeks 24 and 52
measure: Absolute change in fasting plasma glucose
timeFrame: From baseline to weeks 24 and 52
measure: Absolute change in body weight
timeFrame: From baseline to weeks 24 and 52
Other outcomes:
Locations:
city: Adachi-Ku
country: Japan
facility: Investigational Site Number 392335
city: Chiba-Shi
country: Japan
facility: Investigational Site Number 392325
city: Chiyoda-Ku
country: Japan
facility: Investigational Site Number 392328
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392326
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392327
city: Chuoh-Ku
country: Japan
facility: Investigational Site Number 392310
city: Kagoshima-Shi
country: Japan
facility: Investigational Site Number 392336
city: Kamakura-Shi
country: Japan
facility: Investigational Site Number 392314
city: Kashiwara-Shi
country: Japan
facility: Investigational Site Number 392334
city: Kawagoe-Shi
country: Japan
facility: Investigational Site Number 392304
city: Kawaguchi-Shi
country: Japan
facility: Investigational Site Number 392306
city: Kisarazu-Shi
country: Japan
facility: Investigational Site Number 392307
city: Koriyama-Shi
country: Japan
facility: Investigational Site Number 392301
city: Mitaka-Shi
country: Japan
facility: Investigational Site Number 392312
city: Mito-Shi
country: Japan
facility: Investigational Site Number 392302
city: Mito-Shi
country: Japan
facility: Investigational Site Number 392324
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392331
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392332
city: Ohta-Ku
country: Japan
facility: Investigational Site Number 392329
city: Okawa-Shi
country: Japan
facility: Investigational Site Number 392322
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392333
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392330
city: Saijo-Shi
country: Japan
facility: Investigational Site Number 392320
city: Sakado-Shi
country: Japan
facility: Investigational Site Number 392303
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392311
city: Shizuoka-Shi
country: Japan
facility: Investigational Site Number 392316
city: Suita-Shi
country: Japan
facility: Investigational Site Number 392319
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: