Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
NCT ID: NCT02200991
Last Updated: 2016-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
136 participants
INTERVENTIONAL
2014-08-31
2015-11-30
Brief Summary
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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
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Detailed Description
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13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous
Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
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.
Sitagliptin
Pharmaceutical form:tablet Route of administration: oral
Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Interventions
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LIXISENATIDE AVE0010
Pharmaceutical form:solution Route of administration: subcutaneous
Sitagliptin
Pharmaceutical form:tablet Route of administration: oral
Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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, , Japan
Investigational Site Number 392-126
Kumamoto, , Japan
Investigational Site Number 392-127
Kumamoto, , Japan
Investigational Site Number 392-101
Kyoto, , Japan
Investigational Site Number 392-106
Matsudo-shi, , Japan
Investigational Site Number 392-124
Mitaka-shi, , Japan
Investigational Site Number 392-108
Mito, , Japan
Investigational Site Number 392-119
Nerima-ku, , Japan
Investigational Site Number 392-117
Okayama, , Japan
Investigational Site Number 392-111
Sagamihara-shi, , Japan
Investigational Site Number 392-110
Sapporo, , Japan
Investigational Site Number 392-116
Satsumasendai-shi, , Japan
Investigational Site Number 392-105
Shizuoka, , Japan
Investigational Site Number 392-118
Suita-shi, , Japan
Countries
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References
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Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.
Other Identifiers
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U1111-1159-5323
Identifier Type: -
Identifier Source: secondary_id
LIXISL06651
Identifier Type: -
Identifier Source: org_study_id
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