Clinical trial NCT01123980: Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment
Official title: An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insulin Naive Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 521
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months
* Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months
* Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months
* Insulin naive
* HbA1c between 7.0% and 10.0%
* FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)
* Body Mass Index (BMI) below 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial
* Any disease or condition which the Investigator feels would interfere with the trial
* Any contraindication to metformin or glimepiride (according to local labelling)

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, week 24
Secondary outcomes:
measure: 9-point Plasma Glucose Profiles
timeFrame: Week 24
measure: Percentage of Subjects Achieving HbA1c Below 7.0%
timeFrame: Week 24
measure: Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
timeFrame: Week 24
measure: Number of Hypoglycaemic Episodes - All
timeFrame: Weeks 0-24
measure: Number of Hypoglycaemic Episodes - Severe and Minor
timeFrame: Weeks 0-24
measure: Number of Hypoglycaemic Episodes
timeFrame: Weeks 0-24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Chongqing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Fuzhou
country: China
facility: Novo Nordisk Investigational Site
state: Fujian
city: Harbin
country: China
facility: Novo Nordisk Investigational Site
state: Heilongjiang
city: Zhengzhou
country: China
facility: Novo Nordisk Investigational Site
state: Henan
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Dalian
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Xi'an
country: China
facility: Novo Nordisk Investigational Site
state: Shaanxi
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
state: Tianjin
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
state: Tianjin
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
city: Tianjin
country: China
facility: Novo Nordisk Investigational Site
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Gifu city, Gifu
country: Japan
facility: Novo Nordisk Investigational Site
city: Higashi-ku
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto-shi,Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Minato-ku
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi, Osaka
country: Japan
facility: Novo Nordisk Investigational Site
city: Osaka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuka-gun
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shizuoka-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Tagajo-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama-shi
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Yang W, Xu X, Liu X, Yang G, Seino Y, Andersen H, Jinnouchi H. Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naive subjects with type 2 diabetes. Curr Med Res Opin. 2013 Dec;29(12):1599-608. doi: 10.1185/03007995.2013.838155. Epub 2013 Sep 23.