Clinical trial NCT01353469: Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy
Official title: A Multicenter, Randomized, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of Insuman Comb 25 (Insulin Human) Versus Novolin® 30R Twice Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus Who Are Under Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

* To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus on fasting plasma glucose (FPG)
* To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients with type 2 diabetes mellitus

Detailed description: The study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks open-label treatment + 1 week follow-up).

Eligibility criteria: Inclusion criteria:

* Type 2 diabetes mellitus patients, as defined by World Health Organization (WHO), diagnosed for at least 1 year at the time of screening visit who are under premix insulin therapy, with or without oral anti-diabetic drug (OAD)
* Signed written informed consent

Exclusion criteria:

* HbA1c \<7% or HbA1c \>10% at screening
* No self-monitoring of blood glucose within 3 months prior to screening visit
* Premix insulin treatment for less than 3 months. Insulins other than premix insulin treatment within 3 months prior to screening visit
* In case of treatment with OAD, treatment with a stable OAD dose and regimen for less than 3 months prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in HbA1c from baseline to the end of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in fasting plasma glucose from baseline to the end of treatment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156024
city: Beijing
country: China
facility: Investigational Site Number 156010
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Changchun
country: China
facility: Investigational Site Number 156033
city: Changchun
country: China
facility: Investigational Site Number 156017
city: Changsha
country: China
facility: Investigational Site Number 156005
city: Chengdu
country: China
facility: Investigational Site Number 156021
city: Chongqing
country: China
facility: Investigational Site Number 156006
city: Hangzhou
country: China
facility: Investigational Site Number 156032
city: Harbin
country: China
facility: Investigational Site Number 156007
city: Hefei
country: China
facility: Investigational Site Number 156020
city: Nanjing
country: China
facility: Investigational Site Number 156016
city: Nanjing
country: China
facility: Investigational Site Number 156018
city: Shanghai
country: China
facility: Investigational Site Number 156002
city: Shanghai
country: China
facility: Investigational Site Number 156023
city: Shanghai
country: China
facility: Investigational Site Number 156031
city: Shanghai
country: China
facility: Investigational Site Number 156004
city: Shenyang
country: China
facility: Investigational Site Number 156027
city: Suzhou
country: China
facility: Investigational Site Number 156029
city: Tianjin
country: China
facility: Investigational Site Number 156025
city: Wuhan
country: China
facility: Investigational Site Number 156003
city: Xi'An
country: China
facility: Investigational Site Number 156008
city: Xi'An
country: China
facility: Investigational Site Number 156009
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: