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Trial record 43 of 61 for:    Lixisenatide

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

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ClinicalTrials.gov Identifier: NCT02200991
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29.

Secondary Objectives:

To demonstrate:

  • Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
  • Delaying gastric emptying (13C-acetic acid breath test)
  • Safety and tolerability

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: LIXISENATIDE AVE0010 Drug: Sitagliptin Drug: Insulin glargine HOE901 Phase 4

Detailed Description:

The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances.

13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lixisenatide

Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks.

Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Drug: LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus

Active Comparator: Sitagliptin - Januvia

50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks.

Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Drug: Sitagliptin
Pharmaceutical form:tablet Route of administration: oral
Other Name: Januvia

Drug: Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Name: Lantus




Primary Outcome Measures :
  1. Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast [ Time Frame: Day 29 after first intake of investigational product ]

Secondary Outcome Measures :
  1. Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast [ Time Frame: Day 29 after first intake of investigational product ]
  2. Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast [ Time Frame: Day 29 after first intake of investigational product ]
  3. Change from baseline in glucagon levels at Day 29 after a standardized breakfast [ Time Frame: Day 29 after first intake of investigational product ]
  4. Change in gastric emptying half life (13C-acetic acid breath test) [ Time Frame: Day 29 after first intake of investigational product ]
  5. Proportion of patients with adverse events [ Time Frame: Up to Day 33 from the first intake of investigational medicinal product ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis
  • Aged 20-75 years
  • Hemoglobin A1C ≥7.0%-≤10.0%
  • Fasting plasma glucose ≤180 mg/dL at screening
  • Stable treatment (±20%) with Lantus for 3 months or more prior to screening.
  • Sulfonylurea dose stable for 3 months or more prior to screening

Exclusion criteria:

  • Type 1 diabetes mellitus
  • Pregnancy or lactation
  • Hypersensitivity to Lixisenatide
  • Severely uncontrolled glycemic situation
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
  • History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
  • History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
  • Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg
  • Amylase and/or lipase >3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >2 times the upper limit of the normal laboratory range
  • End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200991


Locations
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Japan
Investigational Site Number 392-107
Atsugi-shi, Japan
Investigational Site Number 392-125
Chiyoda-ku, Japan
Investigational Site Number 392-121
Chuoh-ku, Japan
Investigational Site Number 392-102
Ichihara-shi, Japan
Investigational Site Number 392-103
Kawaguchi-shi, Japan
Investigational Site Number 392-114
Kitamoto-shi, Japan
Investigational Site Number 392-122
Kobe-shi, Japan
Investigational Site Number 392-126
Kumamoto-shi, Japan
Investigational Site Number 392-127
Kumamoto-shi, Japan
Investigational Site Number 392-101
Kyoto-shi, Japan
Investigational Site Number 392-106
Matsudo-shi, Japan
Investigational Site Number 392-124
Mitaka-shi, Japan
Investigational Site Number 392-108
Mito-shi, Japan
Investigational Site Number 392-119
Nerima-ku, Japan
Investigational Site Number 392-117
Okayama-shi, Japan
Investigational Site Number 392-111
Sagamihara-shi, Japan
Investigational Site Number 392-110
Sapporo-shi, Japan
Investigational Site Number 392-116
Satsumasendai-shi, Japan
Investigational Site Number 392-105
Shizuoka-shi, Japan
Investigational Site Number 392-118
Suita-shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02200991     History of Changes
Other Study ID Numbers: LIXISL06651
U1111-1159-5323 ( UTN )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Sitagliptin Phosphate
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action