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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353469

Acronym

Insuman-C25-CN

Enrollment

485

Registered

2011-05-13

Start date

2011-05-31

Completion date

2012-11-30

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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).

Interventions

DRUGInsulin human/Insuman Comb 25 (HR1799)

Pharmaceutical form:Suspension Route of administration: Subcutaneous

DRUGInsulin human/Novolin® 30R

Pharmaceutical form:Suspension Route of administration: Subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline to the end of treatment	24 weeks

Secondary

Measure	Time frame
Change in fasting plasma glucose from baseline to the end of treatment	24 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026