Diabetes Mellitus Type 1Phase 4BASNCT01271517
Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis
A Phase 4 study testing NPH insulin, Glargine and Detemir in people with Diabetes Mellitus Type 1, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- NPH insulin, Glargine and Detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2005to Mar 2011
- Phase
- Phase 4
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of diabetes and novel to insulin therapy
- Age 7 - 17 years
- Informed consent
Who cannot join
- Moderate to severe ketoacidosis (pH<7.2 and/or standard bicarbonate <10 mmol/l)
- Suspected non-type 1
- IA2 and GAD65: all-antibody negative
- Celiac disease or other chronic disease
- Hypothyroidism, if not well controlled
- Syndromes
Show all 9Show fewer
- Previous anorexia nervosa
- Neuro-psychiatric disease
- Malignancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of Pediatrics, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents
Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.
This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- NPH insulin, Glargine, Detemir
- Keywords
- Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPH insulinDrug
Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
GlargineDrug
Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
DetemirDrug
Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
| Study group | Role | What they receive |
|---|---|---|
| Insulatard | Active comparator | Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars Receives: Drug: NPH insulin |
| Lantus | Active comparator | Treatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars Receives: Drug: Glargine |
| Levemir | Active comparator | Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars Receives: Drug: Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The study compare HbA1c one year after start of treatment at diagnosis of T1DM in patients treated with Lantus or Levemir with patients treated with Insulatard.
Measured: 1 year
Secondary outcomes (2)
Stimulated C-peptide
Sustacal stimulated C-peptide after an overnight fast
Measured: 2 weeks and 3, 6 and 12 month
IGF-I
Serum IGF-I concentrations
Measured: diagnosis, 2 weeks, 3,6,9 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startSep 2005
- Primary completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271517
- Sponsor's protocol ID
- Eudract-number 2005-001726-80
- Acronym
- BAS
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2011
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of New Longacting Insulin Analogs on Metabolic Control, Endogenous Insulin Production, GH/IGF-I Axis and Quality of Life - Comparison of NPH, Glargine Och Detemir Insulin From the Debut of Type 1 Diabetes Mellitus in Adolescents
- ClinicalTrials.gov ID
- NCT01271517
- Acronym / sponsor ID
- BAS / Eudract-number 2005-001726-80
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Basal insulin, long acting insulin analogs, metabolic control, HbA1c, C-peptide, IGF-I, GH, IGFBP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Mar 2011 (estimated)
- First posted
- 6 Jan 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.
Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.
This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulatard | Active comparator | Drug: NPH insulinTreatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugars |
| Lantus | Active comparator | Drug: GlargineTreatment once daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars |
| Levemir | Active comparator | Drug: DetemirTreatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of diabetes and novel to insulin therapy
- Age 7 - 17 years
- Informed consent
Key exclusion criteria (9 listed)
- Moderate to severe ketoacidosis (pH<7.2 and/or standard bicarbonate <10 mmol/l)
- Suspected non-type 1
- IA2 and GAD65: all-antibody negative
- Celiac disease or other chronic disease
- Hypothyroidism, if not well controlled
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 |
|---|---|---|
| NPH insulinTreatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar | Drug | Insulatard |
| GlargineTreatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars | Drug | Lantus |
| DetemirTreatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars | Drug | Levemir |
Primary outcome
HbA1c
Time frame: 1 year
The study compare HbA1c one year after start of treatment at diagnosis of T1DM in patients treated with Lantus or Levemir with patients treated with Insulatard.
2 secondary outcomes
Stimulated C-peptide
Time frame: 2 weeks and 3, 6 and 12 month
IGF-I
Time frame: diagnosis, 2 weeks, 3,6,9 and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NPH insulin, Glargine and Detemir in people with Diabetes Mellitus Type 1, run by Karolinska Institutet at 1 site in Sweden.
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 9 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: status not confirmed, as of the sponsor's last update on 6 Jan 2011. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 (time frame: 1 year). 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 6 Jan 2011.