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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1159-5323 | UTN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide | Experimental | 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. |
|
| Sitagliptin - Januvia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIXISENATIDE AVE0010 | Drug | Pharmaceutical form:solution Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast | Day 29 after first intake of investigational product |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast | Day 29 after first intake of investigational product | |
| Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392-107 | Atsugi-shi | Japan | ||||
| Investigational Site Number 392-125 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28345162 | Derived | 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. |
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| Sitagliptin | Drug | Pharmaceutical form:tablet Route of administration: oral |
|
|
| Insulin glargine HOE901 | Drug | Pharmaceutical form:solution Route of administration: subcutaneous |
|
|
| Day 29 after first intake of investigational product |
| Change from baseline in glucagon levels at Day 29 after a standardized breakfast | Day 29 after first intake of investigational product |
| Change in gastric emptying half life (13C-acetic acid breath test) | Day 29 after first intake of investigational product |
| Proportion of patients with adverse events | Up to Day 33 from the first intake of investigational medicinal product |
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C479460 | lixisenatide |
| D000068900 | Sitagliptin Phosphate |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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