A dose range finding study of novel oral insulin (IN‐105) under fed conditions in type 2 diabetes mellitus subjects

餐后 安慰剂 医学 胰岛素 内科学 二甲双胍 餐食 加药 糖尿病 内分泌学 2型糖尿病 病理 替代医学
作者
Anand Khedkar,Harish Iyer,Anil C. Anand,Manish Verma,S. Krishnamurthy,S. S Savale,A. Atignal
出处
期刊:Diabetes, Obesity and Metabolism [Wiley]
卷期号:12 (8): 659-664 被引量:64
标识
DOI:10.1111/j.1463-1326.2010.01213.x
摘要

The objective of the study was to establish the dose response of IN-105 tablets and explore a possible therapeutic window in type 2 diabetes subjects poorly controlled on metformin.The primary objective was to examine the effect of sequential single ascending doses of IN-105 on the plasma glucose concentration under fed conditions. All subjects received, sequentially, matching placebo, 10, 15, 20 and 30 mg IN-105 tablets in five consecutive periods. Tablets were administered 20 min prior to meal in all the periods. Plasma levels of immunoreactive insulin, C-peptide and glucose were measured up to 180 min from the time of dosing. The changes in postprandial glucose levels at 120 min in response to IN-105 administration were also compared against those of placebo.Changes in glucose from baseline (mean +/- s.d.) at 140 min (2 h postprandial) were 94.84 +/- 22.3, 79.45 +/- 43.00, 70.68 +/- 35.71, 63.47 +/- 42.75 and 53.06 +/- 47.27 mg/dL, respectively, and exhibited linear dose-response. The insulin C(max) values were found to be 50.8 +/- 26.0 mU/L for placebo, 100.3 +/- 66.7 with 10 mg IN-105, 177.69 +/- 150.3 with 15 mg IN-105, 246.2 +/- 245.2 with 20 mg IN-105 and 352.5 +/- 279.3 mU/L with 30 mg of IN-105.IN-105 absorption is proportional to the dose administered. The 2-h postprandial glucose excursion was reduced in a dose proportional manner. Circulating C-peptide levels were found to be suppressed in proportion to the IN-105 exposure. IN-105 reduces glucose excursion despite lower endogenous insulin secretion. IN-105 seems to have a wide therapeutic window as no clinical hypoglycaemia was observed at any of the doses studied.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
刚刚
stayreal发布了新的文献求助10
1秒前
宋小九完成签到,获得积分10
2秒前
3秒前
李繁蕊发布了新的文献求助10
3秒前
like关注了科研通微信公众号
3秒前
4秒前
4秒前
4秒前
jiajia发布了新的文献求助10
5秒前
丘比特应助lllllljmjmjm采纳,获得10
5秒前
5秒前
wjx发布了新的文献求助10
5秒前
6秒前
6秒前
在水一方应助hui采纳,获得10
6秒前
神奇小鹿完成签到,获得积分10
7秒前
一剑温柔完成签到 ,获得积分10
7秒前
英吉利25发布了新的文献求助10
7秒前
欣欣完成签到,获得积分10
7秒前
wq发布了新的文献求助30
7秒前
8秒前
Orange应助研友_ZAxX6n采纳,获得30
8秒前
Grace完成签到,获得积分10
9秒前
mob完成签到,获得积分10
10秒前
欣欣发布了新的文献求助10
10秒前
stayreal完成签到,获得积分10
10秒前
binxman发布了新的文献求助10
11秒前
11秒前
gu完成签到 ,获得积分10
11秒前
老张发布了新的文献求助10
11秒前
烟花应助风趣的老太采纳,获得10
12秒前
12秒前
研友_VZG7GZ应助嘉子采纳,获得10
13秒前
梦XING发布了新的文献求助10
14秒前
濮阳天与完成签到,获得积分10
14秒前
哈哈发布了新的文献求助10
15秒前
完美世界应助sdl采纳,获得10
15秒前
ZhangLU完成签到,获得积分10
16秒前
高分求助中
Picture Books with Same-sex Parented Families: Unintentional Censorship 700
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
Effective Learning and Mental Wellbeing 300
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3974882
求助须知:如何正确求助?哪些是违规求助? 3519431
关于积分的说明 11198315
捐赠科研通 3255698
什么是DOI,文献DOI怎么找? 1797904
邀请新用户注册赠送积分活动 877237
科研通“疑难数据库(出版商)”最低求助积分说明 806219