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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01940965
First received: September 9, 2013
Last updated: November 25, 2014
Last verified: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, 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: November 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 25, 2014