DiabetesUPGRADENCT00698126
Observational Study of Patients Using NovoRapid® or Soluble Human Insulin for Treatment of Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Italy.
Trial summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- soluble human insulin and biphasic insulin aspart
- How many people
- 4,099 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to May 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: Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study
Who may be able to join
- Patients with type 2 diabetes
- Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years
Who cannot join
- Patients with an end-stage renal failure
- Patients with a serious liver disease
- Patients with concomitant malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study
This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- soluble human insulin, biphasic insulin aspart
- 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.
soluble human insulinDrug
Also called Actrapid
Observational study; use of the products as in the normal clinical practice conditions
biphasic insulin aspartDrug
Observational study; use of the products as in the normal clinical practice conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: soluble human insulin | |
| B | Not described Receives: Drug: biphasic insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major hypoglycaemic events reported as serious adverse drug reactions
Measured: after 26 weeks
Secondary outcomes (9)
Number of serious and non serious drug reactions
Measured: during 26 weeks
Number of serious adverse event
Measured: during 26 weeks
Number of all major (daytime and nocturnal) 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 major hypoglycaemic events related to physical exercise of at least 30 min duration
Measured: during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit
Measured: after 26 weeks
Weight and waist circumference change
Measured: during 26 weeks
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level
Measured: after 26 weeks
Quality of Life (QoL)
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 posted17 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2009
- Study completionMay 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
- 4,099 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
- NCT00698126
- Sponsor's protocol ID
- ANA-1897
- Acronym
- UPGRADE
- 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
- A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Aspart (NovoRapid® ) or Soluble Human Insulin for the Treatment of Diabetes Mellitus the UPGRADE Study
- ClinicalTrials.gov ID
- NCT00698126
- Acronym / sponsor ID
- UPGRADE / ANA-1897
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,099 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 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 Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: soluble human insulin |
| B | – | Drug: biphasic insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any subject with type 2 diabetes who is already in treatment with insulin aspart or soluble human insulin will be included in the study
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes
- Treatment with Insulin Aspart (NovoRapid®) or Soluble Human Insulin for minimum 3 months and maximum 3 years
Key exclusion criteria (3 listed)
- Patients with an end-stage renal failure
- Patients with a serious liver disease
- Patients with concomitant malignant disease
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 |
|---|---|---|
| soluble human insulinAlso: ActrapidObservational study; use of the products as in the normal clinical practice conditions | Drug | A |
| biphasic insulin aspartObservational study; use of the products as in the normal clinical practice conditions | Drug | B |
Primary outcome
Number of major hypoglycaemic events reported as serious adverse drug reactions
Time frame: after 26 weeks
9 secondary outcomes
Number of serious and non serious drug reactions
Time frame: during 26 weeks
Number of serious adverse event
Time frame: during 26 weeks
Number of all major (daytime and nocturnal) 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 major hypoglycaemic events related to physical exercise of at least 30 min duration
Time frame: during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit
Time frame: after 26 weeks
Weight and waist circumference change
Time frame: during 26 weeks
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level
Time frame: after 26 weeks
Quality of Life (QoL)
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 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 2, run by Novo Nordisk A/S at 1 site in Italy.
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 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 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 Italy. 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?
Number of major hypoglycaemic events reported as serious adverse drug reactions (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 28 Oct 2016.