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Trial record 33 of 63 for:    Lixisenatide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940965
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date August 4, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
Safety over 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2013)
  • Absolute change in HbA1c [ Time Frame: From baseline to weeks 24 and 52 ]
  • Absolute change in fasting plasma glucose [ Time Frame: From baseline to weeks 24 and 52 ]
  • Absolute change in body weight [ Time Frame: From baseline to weeks 24 and 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: lixisenatide AVE0010
    Pharmaceutical form:solution Route of administration: Subcutaneous injection
  • Drug: biguanide
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: TZD
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: alpha-GI
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: glinide
    Pharmaceutical form:tablet Route of administration: oral
Study Arms  ICMJE
  • Experimental: Lixisenatide + Biguanide
    52-week treatment with Lixisenatide in combination with biguanide (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: biguanide
  • Experimental: Lixisenatide + TZD
    52-week treatment with lixisenatide in combination with TZD (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: TZD
  • Experimental: Lixisenatide + alpha-GI
    52-week treatment with Lixisenatide in combination with alpha-GI (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: alpha-GI
  • Experimental: Lixisenatide + Glinide
    52-week treatment with Lixisenatide in combination with glinide (usual maintenance dose in the label)
    Interventions:
    • Drug: lixisenatide AVE0010
    • Drug: glinide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
294
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2013)
292
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940965
Other Study ID Numbers  ICMJE LTS12809
U1111-1129-8754 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP