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 - Full Text View

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Insulin human/Insuman Comb 25 (HR1799) Drug: Insulin human/Novolin® 30R	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Change in HbA1c from baseline to the end of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in fasting plasma glucose from baseline to the end of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	485
Study Start Date:	May 2011
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Insuman Comb 25 Insuman 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.	Drug: Insulin human/Insuman Comb 25 (HR1799) Pharmaceutical form:Suspension Route of administration: Subcutaneous
Active Comparator: Novolin® 30R Novolin® 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	Drug: Insulin human/Novolin® 30R Pharmaceutical form:Suspension Route of administration: Subcutaneous

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353469

Locations

China
Investigational Site Number 156001
Beijing, China, 100853
Investigational Site Number 156010
Beijing, China, 100730
Investigational Site Number 156024
Beijing, China, 100088
Investigational Site Number 156033
Changchun, China, 130011
Investigational Site Number 156017
Changchun, China, 130041
Investigational Site Number 156005
Changsha, China, 410008
Investigational Site Number 156021
Chengdu, China, 610072
Investigational Site Number 156006
Chongqing, China, 400016
Investigational Site Number 156032
Hangzhou, China, 310013
Investigational Site Number 156007
Harbin, China, 150001
Investigational Site Number 156020
Hefei, China, 230001
Investigational Site Number 156016
Nanjing, China, 210006
Investigational Site Number 156018
Nanjing, China, 210011
Investigational Site Number 156023
Shanghai, China, 200040
Investigational Site Number 156002
Shanghai, China, 200003
Investigational Site Number 156031
Shanghai, China, 200062
Investigational Site Number 156004
Shanghai, China, 200065
Investigational Site Number 156027
Shenyang, China, 110022
Investigational Site Number 156029
Suzhou, China, 215004
Investigational Site Number 156025
Tianjin, China, 300052
Investigational Site Number 156003
Wuhan, China, 430022
Investigational Site Number 156009
Xi'An, China, 710061
Investigational Site Number 156008
Xi'An, China, 710032

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01353469 History of Changes
Other Study ID Numbers:	EFC12059, U1111-1120-0701
Study First Received:	May 12, 2011
Last Updated:	February 26, 2013
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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)