Type 2 Diabetes MellitusPhase 3Insuman-C25-CNNCT01353469
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 Phase 3 study testing Insulin human/Insuman Comb 25 (HR1799) and Insulin human/Novolin® 30R in people with Type 2 Diabetes Mellitus, run by Sanofi at 23 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Insulin human/Insuman Comb 25 (HR1799) and Insulin human/Novolin® 30R
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 23 sitesChina
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Investigational Site Number 156024
Beijing, 100088
Investigational Site Number 156010
Beijing, 100730
Investigational Site Number 156001
Beijing, 100853
Investigational Site Number 156033
Changchun, 130011
Investigational Site Number 156017
Changchun, 130041
Investigational Site Number 156005
Changsha, 410008
Investigational Site Number 156021
Chengdu, 610072
Investigational Site Number 156006
Chongqing, 400016
Investigational Site Number 156032
Hangzhou, 310013
Investigational Site Number 156007
Harbin, 150001
Investigational Site Number 156020
Hefei, 230001
Investigational Site Number 156016
Nanjing, 210006
Investigational Site Number 156018
Nanjing, 210011
Investigational Site Number 156002
Shanghai, 200003
Investigational Site Number 156023
Shanghai, 200040
Investigational Site Number 156031
Shanghai, 200062
Investigational Site Number 156004
Shanghai, 200065
Investigational Site Number 156027
Shenyang, 110022
Investigational Site Number 156029
Suzhou, 215004
Investigational Site Number 156025
Tianjin, 300052
Investigational Site Number 156003
Wuhan, 430022
Investigational Site Number 156008
Xi'an, 710032
Investigational Site Number 156009
Xi'an, 710061
About this study
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
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
Read the 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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin human/Insuman Comb 25 (HR1799), Insulin human/Novolin® 30R
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin human/Insuman Comb 25 (HR1799)Drug
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Insulin human/Novolin® 30RDrug
Pharmaceutical form:Suspension
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Insuman Comb 25 | Experimental | 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. Receives: Drug: Insulin human/Insuman Comb 25 (HR1799) |
| Novolin® 30R | Active comparator | 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 Receives: Drug: Insulin human/Novolin® 30R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to the end of treatment
Measured: 24 weeks
Secondary outcomes (1)
Change in fasting plasma glucose from baseline to the end of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353469
- Sponsor's protocol ID
- EFC12059
- Other IDs
- U1111-1120-0701
- Acronym
- Insuman-C25-CN
- Status last verified
- Feb 2013
- First submitted
- 12 May 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01353469
- Acronym / sponsor ID
- Insuman-C25-CN / EFC12059
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insuman Comb 25 | Experimental | Drug: Insulin human/Insuman Comb 25 (HR1799)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. |
| Novolin® 30R | Active comparator | Drug: Insulin human/Novolin® 30RNovolin® 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin human/Insuman Comb 25 (HR1799)Pharmaceutical form:Suspension Route of administration: Subcutaneous | Drug | Insuman Comb 25 |
| Insulin human/Novolin® 30RPharmaceutical form:Suspension Route of administration: Subcutaneous | Drug | Novolin® 30R |
Primary outcome
Change in HbA1c from baseline to the end of treatment
Time frame: 24 weeks
1 secondary outcome
Change in fasting plasma glucose from baseline to the end of treatment
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin human/Insuman Comb 25 (HR1799) and Insulin human/Novolin® 30R in people with Type 2 Diabetes Mellitus, run by Sanofi at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline to the end of treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.