DiabetesNCT00698269
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Saudi Arabia.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir, biphasic insulin aspart 30 and insulin aspart
- How many people
- 5,926 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2008to Aug 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A non-randomized sample of Type 1 or Type 2 diabetics
Who may be able to join
- Type 1 or type 2 diabetes
- Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
- Selection will be at the discretion of the individual physician
Who cannot join
- Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
- Previous enrolled in this study
- Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.
- Being tested
- insulin detemir, biphasic insulin aspart 30, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
Also called Levemir®
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
biphasic insulin aspart 30Drug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
insulin aspartDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir | |
| B | Not described Receives: Drug: biphasic insulin aspart 30 | |
| C | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major hypoglycaemic events reported
Measured: during 24 weeks of treatment
Change in HbA1c
Measured: during 24 weeks of treatment
Secondary outcomes (7)
Percentage of subjects achieving HbA1c below 7.0%
Measured: at 12 & 24 weeks
Change in FPG
Measured: at 12 & 24 weeks
Change in PPG
Measured: at 12 & 24 weeks
Body weight
Measured: at 12 & 24 weeks
Change in number of hypoglycaemic events in the last 4 weeks before routine visits
Measured: at 12 & 24 weeks
Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits
Measured: at 12 & 24 weeks
Number of adverse drug reactions (ADR)
Measured: at 12 & 24 weeks
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 startFeb 2008
- Primary completionAug 2009
- Study completionAug 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,926 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
- NCT00698269
- Sponsor's protocol ID
- INS-3532
- Status last verified
- Oct 2016
- First submitted
- 13 Jun 2008
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00698269
- Acronym / sponsor ID
- INS-3532
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,926 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 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 study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
| B | – | Drug: biphasic insulin aspart 30 |
| C | – | Drug: insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A non-randomized sample of Type 1 or Type 2 diabetics
Key inclusion criteria (3 listed)
- Type 1 or type 2 diabetes
- Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid®
- Selection will be at the discretion of the individual physician
Key exclusion criteria (4 listed)
- Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid®
- Previous enrolled in this study
- Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
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 detemirAlso: Levemir®Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| biphasic insulin aspart 30Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | B |
| insulin aspartStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | C |
Primary outcome
Incidence of major hypoglycaemic events reported
Time frame: during 24 weeks of treatment
Change in HbA1c
Time frame: during 24 weeks of treatment
7 secondary outcomes
Percentage of subjects achieving HbA1c below 7.0%
Time frame: at 12 & 24 weeks
Change in FPG
Time frame: at 12 & 24 weeks
Change in PPG
Time frame: at 12 & 24 weeks
Body weight
Time frame: at 12 & 24 weeks
Change in number of hypoglycaemic events in the last 4 weeks before routine visits
Time frame: at 12 & 24 weeks
Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits
Time frame: at 12 & 24 weeks
Number of adverse drug reactions (ADR)
Time frame: at 12 & 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 28 Oct 2016.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Saudi Arabia.
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 3 inclusion and 4 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 28 Oct 2016. 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 Saudi Arabia. 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.
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?
Incidence of major hypoglycaemic events reported (time frame: during 24 weeks of treatment). The study lists 2 primary outcomes in all. 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 28 Oct 2016.