Type 2 Diabetes MellitusPhase 4SPIRITNCT01630369

Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes

A Phase 4 study testing insulin human (HR1799) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective: To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs) Secondary Objectives: To evaluate the percentage of patients with Hb A1c < 7.5%, To evaluate the rate of hypoglycaemia (symptomatic, severe) To… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: insulin human (HR1799)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 552 participants
Where: 1 siteUkraine
Study dates: Feb 2012to May 2013
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
Males and Female > 18 years
HbA1c > 7.5%
Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment

Who cannot join

Type 1 diabetes
Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
Patient planning a pregnancy now or in the next 6 months
The patient is participating in another clinical study now or in the last 28 days prior to Visit 1
The patient is a drug user (currently or in the past)
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

1 site in 1 country.

Ukraine1 site

Sanofi-Aventis Administrative Office
Kyiv

Other trials in Ukraine

About this study

Official title: Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.

Primary Objective:

To evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)

Secondary Objectives:

To evaluate the percentage of patients with Hb A1c < 7.5%,
To evaluate the rate of hypoglycaemia (symptomatic, severe)
To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
To assess the overall safety
To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

Read the detailed description

6 months

Conditions: Type 2 Diabetes Mellitus
Being tested: insulin human (HR1799)
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 (HR1799)Drug
Also called Insuman Basal / Insuman Comb / Insuman Rapid
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Study groups in NCT01630369
Study group	Role	What they receive
Human Insulin	Experimental	Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician. Receives: Drug: insulin human (HR1799)

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease of Hb A1c ≥ 1%
Measured: Baseline, 6 months

Secondary outcomes (6)

Percentage of patients with Hb A1c < 7.5%
Measured: 6 months
Rate of hypoglycaemias (symptomatic, severe)
Measured: 6 months
Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)
Measured: 6 months
Change in FPG
Measured: Baseline 6 months
Number of patients with adverse events
Measured: 6 months
Assessment of efficacy of education courses in Diabetes Schools
Percentage of correct answers after second test compare to the testing of the initial level
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted28 Jun 2012 (estimated)
Study startFeb 2012
Primary completionMay 2013
Study completionMay 2013

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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01630369
Sponsor's protocol ID: HUBIN_L_05574
Other IDs: U1111-1128-8605
Acronym: SPIRIT
Status last verified: May 2014
First submitted: 26 Jun 2012
Last updated: 19 May 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open, Non-randomized 6 Months Study to Evaluate Efficacy and Safety Insuman® Basal, Insuman® Comb 25, Insuman® Rapid in Insulin-naÏve Patients With T2DM Who Received Baseline Education Course in the Diabetes School.
ClinicalTrials.gov ID: NCT01630369
Acronym / sponsor ID: SPIRIT / HUBIN_L_05574
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 28 Jun 2012 (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 evaluate the decrease of Hb A1c ≥ 1% after 6 month treatment in patients with Type 2 Diabetes Mellitus (T2DM) uncontrolled on Oral Antidiabetics (OADs)

Secondary Objectives:

To evaluate the percentage of patients with Hb A1c < 7.5%,
To evaluate the rate of hypoglycaemia (symptomatic, severe)
To evaluate the middle dose of insulin per product - Insuman Basal, Insuman Comb, Insuman Rapid after 6 month treatment
To evaluate the change in Fasting Plasma Glucose (FPG) after 6 month treatment
To assess the overall safety
To evaluate the efficacy of education courses in Diabetes Schools (% of correct answers after second test compare to the testing of the initial level)

Detailed description

6 months

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Human Insulin	Experimental	Drug: insulin human (HR1799)Dosage of human insulin (Insuman Basal/Comb/Rapid) will be individually adjusted in accordance with the Summary of Product Characteristics (SmPC). Patients will follow the titration algorithm recommended by the physician.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

T2DM patients uncontrolled by maximum tolerated dose of 1-2 OADs
Males and Female > 18 years
HbA1c > 7.5%
Patients with abilities of self-monitoring of Diabetes, managing of patient's diary, ability to obtain education in Diabetes School, completion of Questionnaire
It is expected that the patient will remain on a stable dose of OADs within 6 months of treatment

Key exclusion criteria (7 listed)

Type 1 diabetes
Current temporary insulin therapy (gestational diabetes, pancreas cancer, surgery, clinical trial)
Any clinically significant acute major organ or systemic diseases making interpretation of the evaluation results difficult
Patient planning a pregnancy now or in the next 6 months
The patient is participating in another clinical study now or in the last 28 days prior to Visit 1

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 (HR1799)Also: Insuman Basal / Insuman Comb / Insuman RapidPharmaceutical form: solution for injection Route of administration: subcutaneous	Drug	Human Insulin

Primary outcome

Decrease of Hb A1c ≥ 1%
Time frame: Baseline, 6 months

6 secondary outcomes

Percentage of patients with Hb A1c < 7.5%
Time frame: 6 months
Rate of hypoglycaemias (symptomatic, severe)
Time frame: 6 months
Middle dose of insulin per product (Insuman Basal, Insuman Comb, Insuman Rapid)
Time frame: 6 months
Change in FPG
Time frame: Baseline 6 months
Number of patients with adverse events
Time frame: 6 months
Assessment of efficacy of education courses in Diabetes Schools
Time frame: Baseline, 6 months

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 19 May 2014.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin human (HR1799) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Ukraine.

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 5 inclusion and 7 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Decrease of Hb A1c ≥ 1% (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01630369.

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 19 May 2014.