DiabetesPhase 2NCT00698802
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
A Phase 2 study testing EX1000 and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in 3 countries.
Trial summary
This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- EX1000 and biphasic human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Mar 2009
- Phase
- Phase 2
- 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
- Type 2 diabetes for at least 12 months
- Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 9.5%
- FPG (SMPG) less than or equal to 12 mmol/L
Who cannot join
- Treatment with more than 1IU/kg insulin daily
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- Known or suspected allergy to trial products or related products
- Receipt of any investigational drug within one month prior to this trial
- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- EX1000, biphasic human insulin
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EX1000Drug
Treat-to-target titration scheme, s.c. injection
biphasic human insulinDrug
Treat-to-target titration scheme, s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: EX1000 |
| B | Active comparator | Not described Receives: Drug: biphasic human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 8 weeks of treatment
Secondary outcomes (9)
HbA1c
Measured: For the duration of the trial
Fructosamine
Measured: For the duration of the trial
FPG
Measured: For the duration of the trial
4-point SMPG profiles
Measured: For the duration of the trial
Incidence of hypoglycaemic episodes
Measured: For the duration of the trial
Frequency and severity of adverse events (including injection site reactions)
Measured: For the duration of the trial
Laboratory safety parameters (haematology, biochemistry and lipids)
Measured: For the duration of the trial
Physical examination and vital signs
Measured: For the duration of the trial
Total daily insulin dosages
Measured: For the duration of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698802
- Sponsor's protocol ID
- EX1000-1919
- Status last verified
- Apr 2015
- First submitted
- 16 Jun 2008
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00698802
- Acronym / sponsor ID
- EX1000-1919
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jun 2008 (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.
This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EX1000 |
| B | Active comparator | Drug: biphasic human insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes for at least 12 months
- Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 9.5%
- FPG (SMPG) less than or equal to 12 mmol/L
Key exclusion criteria (6 listed)
- Treatment with more than 1IU/kg insulin daily
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- Known or suspected allergy to trial products or related products
- Receipt of any investigational drug within one month prior to this 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 |
|---|---|---|
| EX1000Treat-to-target titration scheme, s.c. injection | Drug | A |
| biphasic human insulinTreat-to-target titration scheme, s.c. injection | Drug | B |
Primary outcome
HbA1c
Time frame: after 8 weeks of treatment
9 secondary outcomes
HbA1c
Time frame: For the duration of the trial
Fructosamine
Time frame: For the duration of the trial
FPG
Time frame: For the duration of the trial
4-point SMPG profiles
Time frame: For the duration of the trial
Incidence of hypoglycaemic episodes
Time frame: For the duration of the trial
Frequency and severity of adverse events (including injection site reactions)
Time frame: For the duration of the trial
Laboratory safety parameters (haematology, biochemistry and lipids)
Time frame: For the duration of the trial
Physical examination and vital signs
Time frame: For the duration of the trial
Total daily insulin dosages
Time frame: For the duration of the trial
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 14 Apr 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EX1000 and biphasic human insulin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 3 sites in 3 countries.
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 6 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, South Africa, United Arab Emirates. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
HbA1c (time frame: after 8 weeks of treatment). 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 14 Apr 2015.