DiabetesNCT01492153
NovoLet® Surveillance Study on Using Human Insulin System in Indonesia
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Indonesia.
Trial summary
This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting. 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?
- biphasic human insulin, isophane human insulin and human soluble insulin
- How many people
- 1,981 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Feb 2003to 5 Sep 2006
- 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: Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study
Who may be able to join
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
- Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia
This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.
- Being tested
- biphasic human insulin, isophane human insulin, human soluble insulin
- 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.
biphasic human insulinDrug
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
isophane human insulinDrug
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
human soluble insulinDrug
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| NovoLet® device | Not described Receives: Drug: biphasic human insulin; Drug: isophane human insulin; Drug: human soluble insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Secondary outcomes (4)
Fasting blood glucose (FBG)
2 hours postprandial blood glucose (2-hr PPBG)
HbA1c (glycosylated haemoglobin)
Adverse events (AEs) including hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study start11 Feb 2003
- Primary completion5 Sep 2006
- Study completion5 Sep 2006
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
- 1,981 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, 1457), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492153
- Sponsor's protocol ID
- NOPEN3-1886
- Status last verified
- Feb 2017
- First submitted
- 12 Dec 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia
- ClinicalTrials.gov ID
- NCT01492153
- Acronym / sponsor ID
- NOPEN3-1886
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,981 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2003 (actual)
- Primary completion
- 5 Sep 2006 (actual)
- Study completion
- 5 Sep 2006 (actual)
- First posted
- 14 Dec 2011 (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 study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoLet® device | – | Drug: biphasic human insulin, Drug: isophane human insulin, Drug: human soluble insulin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
- Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| biphasic human insulinNovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator | Drug | NovoLet® device |
| isophane human insulinNovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator | Drug | NovoLet® device |
| human soluble insulinNovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator | Drug | NovoLet® device |
Primary outcome
Change in body weight
4 secondary outcomes
Fasting blood glucose (FBG)
2 hours postprandial blood glucose (2-hr PPBG)
HbA1c (glycosylated haemoglobin)
Adverse events (AEs) including hypoglycaemic episodes
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 Feb 2017.
- 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, 1457) 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 Indonesia.
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 0 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 Feb 2017. 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 Indonesia. 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?
Change in body weight. 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 Feb 2017.