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

This study is currently recruiting participants.
Verified January 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01940965
First received: September 9, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: lixisenatide AVE0010
Drug: biguanide
Drug: TZD
Drug: alpha-GI
Drug: glinide
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Absolute change in HbA1c [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]
  • Absolute change in fasting plasma glucose [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]
  • Absolute change in body weight [ Time Frame: From baseline to weeks 24 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 292
Study Start Date: September 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide + Biguanide
52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: biguanide
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + TZD
52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: TZD
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + alpha-GI
52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: alpha-GI
Pharmaceutical form:tablet Route of administration: oral
Experimental: Lixisenatide + Glinide
52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
Drug: lixisenatide AVE0010
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Drug: glinide
Pharmaceutical form:tablet Route of administration: oral

Detailed Description:

54 weeks +/-11 days

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940965

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
Japan
Investigational Site Number 392335 Recruiting
Adachi-Ku, Japan
Investigational Site Number 392325 Recruiting
Chiba-Shi, Japan
Investigational Site Number 392328 Recruiting
Chiyoda-Ku, Japan
Investigational Site Number 392327 Recruiting
Chuo-Ku, Japan
Investigational Site Number 392326 Recruiting
Chuo-Ku, Japan
Investigational Site Number 392310 Recruiting
Chuoh-Ku, Japan
Investigational Site Number 392336 Recruiting
Kagoshima-Shi, Japan
Investigational Site Number 392314 Recruiting
Kamakura-Shi, Japan
Investigational Site Number 392334 Recruiting
Kashiwara-Shi, Japan
Investigational Site Number 392304 Recruiting
Kawagoe-Shi, Japan
Investigational Site Number 392306 Recruiting
Kawaguchi-Shi, Japan
Investigational Site Number 392307 Recruiting
Kisarazu-Shi, Japan
Investigational Site Number 392301 Recruiting
Koriyama-Shi, Japan
Investigational Site Number 392312 Recruiting
Mitaka-Shi, Japan
Investigational Site Number 392324 Recruiting
Mito-Shi, Japan
Investigational Site Number 392302 Recruiting
Mito-Shi, Japan
Investigational Site Number 392332 Recruiting
Nagoya-Shi, Japan
Investigational Site Number 392331 Recruiting
Nagoya-Shi, Japan
Investigational Site Number 392329 Recruiting
Ohta-Ku, Japan
Investigational Site Number 392322 Recruiting
Okawa-Shi, Japan
Investigational Site Number 392333 Recruiting
Osaka-Shi, Japan
Investigational Site Number 392330 Recruiting
Sagamihara-Shi, Japan
Investigational Site Number 392320 Recruiting
Saijo-Shi, Japan
Investigational Site Number 392303 Recruiting
Sakado-Shi, Japan
Investigational Site Number 392311 Recruiting
Shinjuku-Ku, Japan
Investigational Site Number 392316 Recruiting
Shizuoka-Shi, Japan
Investigational Site Number 392319 Recruiting
Suita-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01940965     History of Changes
Other Study ID Numbers: LTS12809, U1111-1129-8754
Study First Received: September 9, 2013
Last Updated: January 23, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014