Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02200991
- Lead Sponsor
- 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
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lixisenatide LIXISENATIDE AVE0010 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 Insulin glargine HOE901 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 Insulin glargine HOE901 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 - Januvia Sitagliptin 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.
- Primary Outcome Measures
Name Time Method Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast Day 29 after first intake of investigational product
- Secondary Outcome Measures
Name Time Method 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 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 Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast 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
Trial Locations
- Locations (20)
Investigational Site Number 392-122
🇯🇵Kobe-shi, Japan
Investigational Site Number 392-101
🇯🇵Kyoto-shi, Japan
Investigational Site Number 392-119
🇯🇵Nerima-ku, Japan
Investigational Site Number 392-111
🇯🇵Sagamihara-shi, Japan
Investigational Site Number 392-102
🇯🇵Ichihara-shi, Japan
Investigational Site Number 392-121
🇯🇵Chuoh-ku, Japan
Investigational Site Number 392-108
🇯🇵Mito-shi, Japan
Investigational Site Number 392-127
🇯🇵Kumamoto-shi, Japan
Investigational Site Number 392-106
🇯🇵Matsudo-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
Investigational Site Number 392-114
🇯🇵Kitamoto-shi, Japan
Investigational Site Number 392-125
🇯🇵Chiyoda-ku, Japan
Investigational Site Number 392-107
🇯🇵Atsugi-shi, Japan
Investigational Site Number 392-103
🇯🇵Kawaguchi-shi, Japan
Investigational Site Number 392-124
🇯🇵Mitaka-shi, Japan
Investigational Site Number 392-126
🇯🇵Kumamoto-shi, Japan
Investigational Site Number 392-117
🇯🇵Okayama-shi, Japan