DiabetesDIABESITYNCT00687063
Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in India.
Trial summary
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 10,008 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2008to Feb 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetics
Who may be able to join
- Any subject with type 2 diabetes
Who cannot join
- Subjects with a hypersensitivity to insulin detemir or any of its excipient
- Children below 6 years
- Subjects who are pregnant, lactating or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir
- 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.
insulin detemirDrug
Also called Levemir®
Start dose and frequency of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change from baseline
Measured: after 26 weeks
Secondary outcomes (7)
Number of serious adverse events
Measured: after 26 weeks
Number of all adverse events
Measured: after 26 weeks
Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)
Measured: after 26 weeks
HbA1c change from baseline
Measured: after 26 weeks
FBG (Fasting Blood Glucose) change from baseline
Measured: after 26 weeks
Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %
Measured: after 26 weeks
Insulin dose and frequency at the end of the study
Measured: after 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2009
- Study completionFeb 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,008 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), MD, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687063
- Sponsor's protocol ID
- NN304-3530
- Acronym
- DIABESITY
- Status last verified
- Oct 2023
- First submitted
- 27 May 2008
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Safety and Efficacy Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00687063
- Acronym / sponsor ID
- DIABESITY / NN304-3530
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,008 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 May 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.
The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetics
Key inclusion criteria (1 listed)
- Any subject with type 2 diabetes
Key exclusion criteria (3 listed)
- Subjects with a hypersensitivity to insulin detemir or any of its excipient
- Children below 6 years
- Subjects who are pregnant, lactating or planning to become pregnant
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 of insulin detemir is to be decided by physician. The choice of patient is also at the discretion of Physician | Drug | A |
Primary outcome
Weight change from baseline
Time frame: after 26 weeks
7 secondary outcomes
Number of serious adverse events
Time frame: after 26 weeks
Number of all adverse events
Time frame: after 26 weeks
Number of all hypoglycemic episodes (24 hr, daytime and nocturnal)
Time frame: after 26 weeks
HbA1c change from baseline
Time frame: after 26 weeks
FBG (Fasting Blood Glucose) change from baseline
Time frame: after 26 weeks
Percentage of patients achieving targets of HbA1c less than 7 % and less than 6.5 %
Time frame: after 26 weeks
Insulin dose and frequency at the end of the study
Time frame: after 26 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 2 Nov 2023.
- 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), MD 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 2, run by Novo Nordisk A/S at 1 site in India.
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 1 inclusion and 3 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 2 Nov 2023. 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 India. 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?
Weight change from baseline (time frame: after 26 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 2 Nov 2023.