DiabetesNCT00849316
Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney Disease
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S.
Trial summary
This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from both speciality practice settings who have been deemed appropriate to receive NovoRapid™ as new treatment and as part of routine out-patient care by the prescribing physician.
Who may be able to join
- Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before
- Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™"
Who cannot join
- Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- Subjects with stage V of chronic kidney disease
- Subjects who previously enrolled in this study
- Known or suspected allergy to trial product(s) or related products
About this study
Official title: A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study
This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.
- Being tested
- insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Safety and effectiveness data collection in connection with the use of the drug NovoRapid™ in patients with coexisting diabetes and chronic kidney disease in daily clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| A | 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 episodes
Measured: during 26 weeks
Secondary outcomes (5)
Number of serious adverse events
Measured: during 26 weeks
Number of serious adverse drug reactions
Measured: during 26 weeks
Number of all daytime and nocturnal major hypoglycaemic events
Measured: during 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection
Measured: during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events
Measured: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: Due to company decision to focus resources on the finalisation of three ongoing studies in the region
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ankit Pathak, MD, Study director, Novo Nordisk India LtdAshok Moharana, MD, Study director, Novo Nordisk India Private Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849316
- Sponsor's protocol ID
- ANA-3702
- Status last verified
- Oct 2023
- First submitted
- 20 Feb 2009
- 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
- A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study
- ClinicalTrials.gov ID
- NCT00849316
- Acronym / sponsor ID
- ANA-3702
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to company decision to focus resources on the finalisation of three ongoing studies in the region
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 23 Feb 2009 (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 investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin aspart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from both speciality practice settings who have been deemed appropriate to receive NovoRapid™ as new treatment and as part of routine out-patient care by the prescribing physician.
Key inclusion criteria (2 listed)
- Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before
- Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™"
Key exclusion criteria (4 listed)
- Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
- Subjects with stage V of chronic kidney disease
- Subjects who previously enrolled in this study
- Known or suspected allergy to trial product(s) or related products
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 aspartSafety and effectiveness data collection in connection with the use of the drug NovoRapid™ in patients with coexisting diabetes and chronic kidney disease in daily clinical practice. | Drug | A |
Primary outcome
Incidence of major hypoglycaemic episodes
Time frame: during 26 weeks
5 secondary outcomes
Number of serious adverse events
Time frame: during 26 weeks
Number of serious adverse drug reactions
Time frame: during 26 weeks
Number of all daytime and nocturnal major hypoglycaemic events
Time frame: during 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection
Time frame: during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events
Time frame: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Ankit Pathak, MD study director
Novo Nordisk India Ltd
Ashok Moharana, MD study director
Novo Nordisk India Private Ltd.
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.
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 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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 episodes (time frame: during 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.