Type 1 DiabetesPhase 4NCT00346996
Insulin Analogues and Severe Hypoglycaemia
A Phase 4 study testing insulin levemir / aspart and human insulin /insulin isophane in people with Type 1 Diabetes, run by Lise Tarnow at 1 site in Denmark.
Trial summary
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- insulin levemir / aspart and human insulin /insulin isophane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for 5 years.
- Age>18 years.
- Two or more episodes of hypoglycaemia during the last year,
Who cannot join
- History of Addisons disease
- Growth hormone deficiency or untreated myxoedema
- CVD within 6 months
- Cancer within 5 years
- Alcohol or drug abuse
- Pregnant or lactating women
Show all 9Show fewer
- Fertile women without effective contraception
- Participation in another trial within 30 days
- Inability to understand the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia
Read the detailed description
The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.
Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.
Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.
Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.
Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.
Outcomes: Severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia Efficacy: Number of reported episodes of severe, documented symptomatic and asymptomatic hypoglycaemia during the last 9 months of treatment - during daytime and night time.
Safety: Adverse reactions
- Conditions
- Type 1 Diabetes
- Being tested
- insulin levemir / aspart, human insulin /insulin isophane
- Keywords
- diabetes, insulin, insulin analogues, hypoglycaemia, severe hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin levemir / aspartDrug
for subcutaneous injection
human insulin /insulin isophaneDrug
for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | HUman Insulin Receives: Drug: human insulin /insulin isophane |
| 2 | Experimental | Analogue insulin Receives: Drug: insulin levemir / aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe hypoglycaemia
Measured: 9 months
Secondary outcomes (3)
asymptomatic hypoglycaemia
Measured: 9 months
hypoglycaemia during nighttime
Measured: 9 months
hypoglycaemia during daytime
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startMay 2007
- Primary completionNov 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lise Tarnow
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Lise Tarnow, Steno Diabetes Center Copenhagen
- Investigators
- Lise Tarnow, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346996
- Sponsor's protocol ID
- HypoAna
- Status last verified
- Aug 2012
- First submitted
- 30 Jun 2006
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen-Bjergaard U, Kristensen PL, Norgaard K, Perrild H, Jensen T, Thorsteinsson B, Nikolajsen A, Tarnow L. Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. Curr Med Res Opin. 2016 Oct;32(10):1719-1725. doi: 10.1080/03007995.2016.1205006. Epub 2016 Jul 20.
PubMed 27326862Agesen RM, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L, Pedersen-Bjergaard U. Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial. Diabetes Metab. 2016 Sep;42(4):249-55. doi: 10.1016/j.diabet.2016.03.001. Epub 2016 Apr 7.
PubMed 27068361Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):553-61. doi: 10.1016/S2213-8587(14)70073-7. Epub 2014 May 2.
PubMed 24794703Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Parving HH, Thorsteinsson B, Tarnow L. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocr Disord. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10.
PubMed 22727048
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00346996
- Acronym / sponsor ID
- HypoAna
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, insulin, insulin analogues, hypoglycaemia, severe hypoglycaemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Lise TarnowUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- May 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Jul 2006 (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.
Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia
Detailed description
The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.
Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.
Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.
Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.
Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.
Outcomes: Severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia Efficacy: Number of reported episodes of severe, documented symptomatic and asymptomatic hypoglycaemia during the last 9 months of treatment - during daytime and night time.
Safety: Adverse reactions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: human insulin /insulin isophaneHUman Insulin |
| 2 | Experimental | Drug: insulin levemir / aspartAnalogue insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes for 5 years.
- Age>18 years.
- Two or more episodes of hypoglycaemia during the last year,
Key exclusion criteria (9 listed)
- History of Addisons disease
- Growth hormone deficiency or untreated myxoedema
- CVD within 6 months
- Cancer within 5 years
- Alcohol or drug abuse
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 levemir / aspartfor subcutaneous injection | Drug | 2 |
| human insulin /insulin isophanefor subcutaneous injection | Drug | 1 |
Primary outcome
Severe hypoglycaemia
Time frame: 9 months
3 secondary outcomes
asymptomatic hypoglycaemia
Time frame: 9 months
hypoglycaemia during nighttime
Time frame: 9 months
hypoglycaemia during daytime
Time frame: 9 months
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 3 Sep 2012.
- Derived from this study: PubMed 27326862Pedersen-Bjergaard U, Kristensen PL, Norgaard K, Perrild H, Jensen T, Thorsteinsson B, Nikolajsen A, Tarnow L. Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. Curr Med Res Opin. 2016 Oct;32(10):1719-1725. doi: 10.1080/03007995.2016.1205006. Epub 2016 Jul 20.
- Derived from this study: PubMed 27068361Agesen RM, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L, Pedersen-Bjergaard U. Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial. Diabetes Metab. 2016 Sep;42(4):249-55. doi: 10.1016/j.diabet.2016.03.001. Epub 2016 Apr 7.
- Derived from this study: PubMed 24794703Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):553-61. doi: 10.1016/S2213-8587(14)70073-7. Epub 2014 May 2.
- Derived from this study: PubMed 22727048Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Parving HH, Thorsteinsson B, Tarnow L. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocr Disord. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10.
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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.
Lise Tarnow, MD principal investigator
Steno Diabetes Center Copenhagen
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 insulin levemir / aspart and human insulin /insulin isophane in people with Type 1 Diabetes, run by Lise Tarnow at 1 site in Denmark.
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: finished, as of the sponsor's last update on 3 Sep 2012. 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 Denmark. 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?
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?
Severe hypoglycaemia (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346996, which also lists 4 linked publications.
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 3 Sep 2012.