DiabetesNCT00715780
Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Indonesia.
Trial summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. 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?
- soluble human insulin, biphasic human insulin and insulin NPH
- How many people
- 1,667 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2008to Jul 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: Type 2 diabetic patients
Who may be able to join
- Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
- Insulin naive
- Poor glycaemic control on OADs and decided by the physician to start insulin therapy
Who cannot join
- Type 1 diabetes patients
- Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Patients with a hypersensitivity to insulin or to any of the excipients
- Patient groups not approved in the product label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- soluble human insulin, biphasic human insulin, insulin NPH, insulin aspart, 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®
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
biphasic human insulinDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
insulin NPHDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
insulin aspartDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
biphasic insulin aspartDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
insulin detemirDrug
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: soluble human insulin; Drug: biphasic human insulin; Drug: insulin NPH; Drug: insulin aspart; Drug: biphasic insulin aspart; Drug: insulin detemir |
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 of insulin therapy
Secondary outcomes (12)
Frequency and type of hypoglycaemic episodes
Measured: during 26 weeks of insulin therapy
Frequency and type of adverse events
Measured: during 26 weeks of insulin therapy
Frequency and type of adverse drug reactions
Measured: during 26 weeks of insulin therapy
Change in HbA1c from baseline
Measured: during 26 weeks of insulin therapy
Change in PPG from baseline
Measured: during 26 weeks of insulin therapy
Change in FPG from baseline
Measured: during 26 weeks of insulin therapy
Subjects' insulin treatment satisfaction
Measured: during 26 weeks of insulin therapy
Physicians' satisfaction with insulin therapy
Measured: during 26 weeks of insulin therapy
Weight change
Measured: at the end of the study
Percentage of patients reaching the target of HbA1c less than 7.5%
Measured: at the end of the study
Percentage of patients reaching the target of HbA1c less than 7%
Measured: at the end of the study
Percentage of patients reaching the target of HbA1c less than 6.5%
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,667 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
- NCT00715780
- Sponsor's protocol ID
- INS-3615
- Status last verified
- Nov 2016
- First submitted
- 14 Jul 2008
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Safety and Efficacy Study in Subjects Using Insulin for the Treatment of Type 2 Diabetes Mellitus Failing on Oral Anti-diabetic Agents
- ClinicalTrials.gov ID
- NCT00715780
- Acronym / sponsor ID
- INS-3615
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,667 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Jul 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 study is conducted in Asia. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes and other adverse events, and to evaluate efficacy while using insulin under normal clinical practice conditions. The switch from OAD treatment to insulin therapy will be determined by physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: soluble human insulin, Drug: biphasic human insulin, Drug: insulin NPH, Drug: insulin aspart, Drug: biphasic insulin aspart, Drug: insulin detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients
Key inclusion criteria (3 listed)
- Type 2 diabetes for at least 12 months and currently receiving oral anti-diabetic (OAD) treatment, whether single or combination, for at least 3 months before this study
- Insulin naive
- Poor glycaemic control on OADs and decided by the physician to start insulin therapy
Key exclusion criteria (4 listed)
- Type 1 diabetes patients
- Patients who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
- Patients with a hypersensitivity to insulin or to any of the excipients
- Patient groups not approved in the product label
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: Actrapid®Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| biphasic human insulinStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| insulin NPHStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| insulin aspartStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| biphasic insulin aspartStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
| insulin detemirStart dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation | Drug | A |
Primary outcome
Incidence of major hypoglycaemic episodes
Time frame: during 26 weeks of insulin therapy
12 secondary outcomes
Frequency and type of hypoglycaemic episodes
Time frame: during 26 weeks of insulin therapy
Frequency and type of adverse events
Time frame: during 26 weeks of insulin therapy
Frequency and type of adverse drug reactions
Time frame: during 26 weeks of insulin therapy
Change in HbA1c from baseline
Time frame: during 26 weeks of insulin therapy
Change in PPG from baseline
Time frame: during 26 weeks of insulin therapy
Change in FPG from baseline
Time frame: during 26 weeks of insulin therapy
Subjects' insulin treatment satisfaction
Time frame: during 26 weeks of insulin therapy
Physicians' satisfaction with insulin therapy
Time frame: during 26 weeks of insulin therapy
Weight change
Time frame: at the end of the study
Percentage of patients reaching the target of HbA1c less than 7.5%
Time frame: at the end of the study
Percentage of patients reaching the target of HbA1c less than 7%
Time frame: at the end of the study
Percentage of patients reaching the target of HbA1c less than 6.5%
Time frame: at the end of the study
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 Nov 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 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 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: finished, as of the sponsor's last update on 7 Nov 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 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?
Incidence of major hypoglycaemic episodes (time frame: during 26 weeks of insulin therapy). 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 Nov 2016.