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
Insuman-C25-CN
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
2 other identifiers
interventional
485
1 country
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started May 2011
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 27, 2013
February 1, 2013
1.5 years
May 12, 2011
February 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline to the end of treatment
24 weeks
Secondary Outcomes (1)
Change in fasting plasma glucose from baseline to the end of treatment
24 weeks
Study Arms (2)
Insuman Comb 25
EXPERIMENTALInsuman Comb 25 will be self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline.
Novolin® 30R
ACTIVE COMPARATORNovolin® 30R will be self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner. The dose will be adjusted individually by monitoring the blood glucose values and symptoms, and following China guideline and the package insert of Novolin® 30R
Interventions
Pharmaceutical form:Suspension Route of administration: Subcutaneous
Pharmaceutical form:Suspension Route of administration: Subcutaneous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (23)
Investigational Site Number 156024
Beijing, 100088, China
Investigational Site Number 156010
Beijing, 100730, China
Investigational Site Number 156001
Beijing, 100853, China
Investigational Site Number 156033
Changchun, 130011, China
Investigational Site Number 156017
Changchun, 130041, China
Investigational Site Number 156005
Changsha, 410008, China
Investigational Site Number 156021
Chengdu, 610072, China
Investigational Site Number 156006
Chongqing, 400016, China
Investigational Site Number 156032
Hangzhou, 310013, China
Investigational Site Number 156007
Harbin, 150001, China
Investigational Site Number 156020
Hefei, 230001, China
Investigational Site Number 156016
Nanjing, 210006, China
Investigational Site Number 156018
Nanjing, 210011, China
Investigational Site Number 156002
Shanghai, 200003, China
Investigational Site Number 156023
Shanghai, 200040, China
Investigational Site Number 156031
Shanghai, 200062, China
Investigational Site Number 156004
Shanghai, 200065, China
Investigational Site Number 156027
Shenyang, 110022, China
Investigational Site Number 156029
Suzhou, 215004, China
Investigational Site Number 156025
Tianjin, 300052, China
Investigational Site Number 156003
Wuhan, 430022, China
Investigational Site Number 156008
Xi'an, 710032, China
Investigational Site Number 156009
Xi'an, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2011
First Posted
May 13, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 27, 2013
Record last verified: 2013-02