DiabetesProMixNCT01536652
Prandial Orientated Biphasic Insulin Aspart 30 Therapy - the Physiological Premix Insulin Therapy for Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30… 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?
- biphasic insulin aspart 30
- How many people
- 4,994 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Nov 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: Any patient with diabetes mellitus type 2, using insulin glargine in combination with one or more OADs, being in inadequate glycaemic control and are indicated to receive biphasic insulin aspart 30
Who may be able to join
- Subjects with diabetes mellitus type 2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2
This study is conducted in Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- biphasic insulin aspart 30
- 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.
biphasic insulin aspart 30Drug
Prescription at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 users | Not described Receives: Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin)
Secondary outcomes (5)
Body weight
Preprandial and postprandial blood glucose values (self measured)
Insulin dosage
Incidence of (serious) adverse drug reactions
Incidence of hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJan 2006
- Primary completionNov 2006
- Study completionNov 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
- 4,994 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
- NCT01536652
- Sponsor's protocol ID
- BIASP-1932
- Acronym
- ProMix
- Status last verified
- Mar 2016
- First submitted
- 16 Feb 2012
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prandial Oriented NovoMix 30® - the Physiological Insulin Therapy of Diabetes Type 2
- ClinicalTrials.gov ID
- NCT01536652
- Acronym / sponsor ID
- ProMix / BIASP-1932
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,994 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Feb 2012 (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 Europe. The aim of this observational study is to document the glycaemic parameters, adverse events, including drug reactions, as well as hypoglycaemic episodes, in patients that switched from insulin glargine combined with oral antidiabetic drugs (OADs) to biphasic insulin aspart 30 (NovoMix® 30) combined with OADs, when applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 users | – | Drug: biphasic insulin aspart 30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with diabetes mellitus type 2, using insulin glargine in combination with one or more OADs, being in inadequate glycaemic control and are indicated to receive biphasic insulin aspart 30
Key inclusion criteria (1 listed)
- Subjects with diabetes mellitus type 2
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 insulin aspart 30Prescription at the discretion of the treating physician | Drug | BIAsp 30 users |
Primary outcome
HbA1c (glycosylated haemoglobin)
5 secondary outcomes
Body weight
Preprandial and postprandial blood glucose values (self measured)
Insulin dosage
Incidence of (serious) adverse drug reactions
Incidence of 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 7 Mar 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 Germany.
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 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 7 Mar 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 Germany. 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?
HbA1c (glycosylated haemoglobin). 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 7 Mar 2016.