DiabetesNCT00665808
Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir and isophane human insulin
- How many people
- 8,125 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Dec 2008
- 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 willing and able to give signed informed consent; Patients with Type 2 diabetes mellitus; Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control; Patients with no regular use of short acting insulin (occasional use for correction is allowed); Patients with no contraindication for use of Protaphane® or Levemir®
Who may be able to join
- Written informed consent obtained from patient before first documentation of treatment in the observational study.
- Type 2 diabetes mellitus
- Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
- No contraindication for use of Protaphane® or Levemir®
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, isophane human insulin
- 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®
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
isophane human insulinDrug
Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: insulin detemir | |
| B | Not described Receives: Drug: isophane human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment satisfaction (DTSQs and DTSQc)
Measured: over whole study duration, 24 weeks per patient
Secondary outcomes (10)
diabetes-related quality of life (ADDQoL)
Measured: over whole study duration, 24 weeks per patient
general health-related quality of life (EQ-5D)
Measured: over whole study duration, 24 weeks per patient
Body weight
Measured: over whole study duration, 24 weeks per patient
metabolic control (HbA1c, fasting morning blood glucose)
Measured: over whole study duration, 24 weeks per patient
Insulin dose
Measured: over whole study duration, 24 weeks per patient
concomitant diabetes therapy (OADs)
Measured: over whole study duration, 24 weeks per patient
Hypoglycemia
Measured: over whole study duration, 24 weeks per patient
Adverse drug reactions, ADR
Measured: over whole study duration, 24 weeks per patient
Serious adverse drug reactions, SADR
Measured: over whole study duration, 24 weeks per patient
Pregnancy
Measured: over whole study duration, 24 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
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
- 8,125 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
- NCT00665808
- Sponsor's protocol ID
- NN304-1951
- Status last verified
- Oct 2016
- First submitted
- 22 Apr 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
- Insulin Detemir (Levemir®) Versus Isophane (NPH) Insulin (Protaphane®) in Combination With Oral Antidiabetic Agents (OAD) in Patients With Diabetes Mellitus Type 2 Comparing Treatment Satisfaction, Diabetes-related and General Health-related Quality of Life, as Well as Diabetes-control
- ClinicalTrials.gov ID
- NCT00665808
- Acronym / sponsor ID
- NN304-1951
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,125 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Apr 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 NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: insulin detemir |
| B | – | Drug: isophane human insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients willing and able to give signed informed consent; Patients with Type 2 diabetes mellitus; Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control; Patients with no regular use of short acting insulin (occasional use for correction is allowed); Patients with no contraindication for use of Protaphane® or Levemir®
Key inclusion criteria (4 listed)
- Written informed consent obtained from patient before first documentation of treatment in the observational study.
- Type 2 diabetes mellitus
- Patients, who should intensify treatment with long acting insulin in addition to their treatment with oral antidiabetic agents, due to insufficient blood glucose control
- No contraindication for use of Protaphane® or Levemir®
Key exclusion criteria (1 listed)
- None
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®Observational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany | Drug | A |
| isophane human insulinObservational study on treatment satisfaction of Levemir ® versus Protaphane® during "real-life" usage in Germany | Drug | B |
Primary outcome
treatment satisfaction (DTSQs and DTSQc)
Time frame: over whole study duration, 24 weeks per patient
10 secondary outcomes
diabetes-related quality of life (ADDQoL)
Time frame: over whole study duration, 24 weeks per patient
general health-related quality of life (EQ-5D)
Time frame: over whole study duration, 24 weeks per patient
Body weight
Time frame: over whole study duration, 24 weeks per patient
metabolic control (HbA1c, fasting morning blood glucose)
Time frame: over whole study duration, 24 weeks per patient
Insulin dose
Time frame: over whole study duration, 24 weeks per patient
concomitant diabetes therapy (OADs)
Time frame: over whole study duration, 24 weeks per patient
Hypoglycemia
Time frame: over whole study duration, 24 weeks per patient
Adverse drug reactions, ADR
Time frame: over whole study duration, 24 weeks per patient
Serious adverse drug reactions, SADR
Time frame: over whole study duration, 24 weeks per patient
Pregnancy
Time frame: over whole study duration, 24 weeks per patient
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 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 4 inclusion and 1 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 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?
treatment satisfaction (DTSQs and DTSQc) (time frame: over whole study duration, 24 weeks per patient). 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.