Diabetes Mellitus, Type 1Phase 4NCT01440439
Comparing Long-acting Insulins During Exercise in Type 1 Diabetes
A Phase 4 study testing Insulin glargine and Insulin detemir in people with Diabetes Mellitus, Type 1, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes are treated with a "basal bolus" insulin regimen, with background insulin provided by long-acting "basal" insulin doses, and "bolus"… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Insulin glargine and Insulin detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 Diabetes Mellitus (T1DM)
- HbA1c < 10% or 86 mmol/mol
- Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin
- Exercising regularly for at least 1 hour per week on average
Who cannot join
- People with any one of the following complications of diabetes:
- stage 2+ diabetic retinopathy
- renal impairment (with creatinine >150micromol/l)
- known history or symptoms of cardiovascular disease
- foot ulceration
- peripheral vascular disease
Show all 14Show fewer
- Pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
- Known or suspected allergy to or intolerance of any of the trial drugs or related products
- Receipt of any investigational drug within four months prior to Visit 0
- Known or suspected abuse of alcohol, narcotics or illicit drugs
- Any clinically significant disease or disorder which in the investigator's opinion could interfere with the results of the trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Wycombe Hospital
High Wycombe, Buckinghamshire, HP11 2TT
About this study
Official title: Impact of Insulin Detemir Versus Insulin Glargine on Glycaemic Control and Metabolism During Exercise in Type 1 Diabetes
Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes are treated with a "basal bolus" insulin regimen, with background insulin provided by long-acting "basal" insulin doses, and "bolus" doses of short-acting insulin used to accompany food intake. Evidence shows that the main factor preventing people with diabetes from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A previous study has shown that the type of background insulin affects the likelihood of an individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards. The aim of this study is to examine this further.
The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with insulin glargine than insulin detemir. Exercise intensity can have an influence on the likelihood of hypoglycaemia, and in this previous study exercise intensity was measured using heart rate. This study will use a more formal definition of exercise intensity. The investigators will study blood glucose during exercise, but also metabolism as measured by hormones affecting blood glucose levels as well as markers of fat metabolism. The investigators will also use a continuous glucose monitoring system (CGMS) to consider hypoglycaemia on thei night following exercise as this is a recognised consequence of exercise in type 1 diabetes.
The null hypothesis to be tested in this study is that there is no difference between the two insulins in their effect on blood glucose levels and metabolism during exercise and rates of nocturnal hypoglycaemia after exercise.
Read the detailed description
A1: At the first appointment, potential participants will be screened regarding the inclusion criteria, and if eligible to take part the study information sheet will be discussed with them in detail. Written, informed consent will be obtained if participants are willing to take part in the study. Participants will be given advice and support from this point in order to optimise basal insulin therapy using their usual basal insulin.
A2: Following a period of at least 3 weeks from recruitment into the study, participants will have their maximal oxygen uptake (VO2 MAX - a measure of capacity for physical exercise) assessed.
A3: After at least 4 weeks following recruitment , to allow time for optimisation of basal insulin therapy, and at least one week following A2, the participant's metabolism will then be assessed during and after 60 minutes of exercise at 50% VO2 MAX. Participants will be fitted with a continuous glucose monitoring system (CGMS) to monitor glucose levels for the 24 hours after exercise finishes.
A4: At least 24 hours and no more than 7 days after A3 the participant will switched to using the other trial insulin for basal insulin therapy. Again, participants will be provided with advice and support in order to optimise treatment.
A5: At least 4 weeks following A4, the participant's metabolism will once again be assessed during and after 60 minutes of exercise at 50% VO2 MAX. Participants will again be fitted with CGMS to monitor glucose levels for the 24 hours after exercise finishes.
A6: Once the 24 hours after exercise are complete, the study finishes and participants re-start their usual basal insulin.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Insulin glargine, Insulin detemir
- Keywords
- insulin glargine, insulin detemir, hypoglycaemia, metabolism, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargineDrug
Also called Lantus
Use of insulin glargine as basal insulin for treatment of Type 1 Diabetes Mellitus
Insulin detemirDrug
Also called Levemir
Use of insulin detemir as basal insulin for treatment of Type 1 Diabetes Mellitus
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir | Active comparator | Metabolism during and after submaximal exercise during treatment with insulin detemir Receives: Drug: Insulin detemir |
| Insulin glargine | Active comparator | Metabolism during and after submaximal exercise during treatment with insulin glargine Receives: Drug: Insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise)
The measure will be a comparison between the two conditions (treatment with insulin detemir or treatment with insulin glargine) of the change in blood glucose levels during one hour of sub-maximal exercise at 50% VO2 MAX
Measured: Between baseline and 1 hour
Secondary outcomes (13)
Lactate
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of blood lactate measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
NEFA (Non-esterified fatty acids)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of NEFA in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
B-OHB (beta-hydroxybutyrate)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of beta-hydroxybutyrate in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
Catecholamines
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of catecholamines in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
Glucagon
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of glucagon in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
Human growth hormone (hGH)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of human Growth Hormone in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
Cortisol
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of cortisol in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
IL-6 (interleukin 6)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of IL-6 in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
High sensitivity CRP (Hs-CRP)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of Hs-CRP in blood measured at the start and the finish of 1 hour of submaximal exercise at 50% VO2 MAX and then 30 minutes following this exercise
Measured: 0, 60 and 90 minutes
RQ (Respiratory Quotient)
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of the ratio of RQ measured at the start of exercise to the RQ at the end of 1 hour of submaximal exercise at 50% VO2 MAX
Measured: Baseline and 1 hour
Frequency of hypoglycaemic events
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of the frequency of hypoglycaemic events (defined as blood glucose < 3.5mmol/l) between the start of 1 hour of exercise at 50% VO2 MAX and 24 hours after the end of this exercise.
Measured: 24 hours
Time spent in hypoglycaemia
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of the time spent in hypoglycaemia (blood glucose <3.5 mmol/l) between the start of 1 hour of exercise at 50% VO2 MAX and 24 hours after the end of this exercise
Measured: 24 hours
Blood glucose
This measure consists of a comparison between the two conditions (treatment with insulin glargine and treatment with insulin detemir) of blood glucose levels measured every 10 minutes from the start of 1 hour of submaximal exercise at 50% VO2 MAX until 30 minutes following this exercise
Measured: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (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.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buckinghamshire Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Ian W Gallen, MD FRCP, Principal investigator, Bcukinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440439
- Sponsor's protocol ID
- RXQ425
- Other IDs
- 2011-001209-28, U1111-1119-8890
- Status last verified
- Nov 2011
- First submitted
- 20 Sep 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Insulin Detemir Versus Insulin Glargine on Glycaemic Control and Metabolism During Exercise in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01440439
- Acronym / sponsor ID
- RXQ425
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- insulin glargine, insulin detemir, hypoglycaemia, metabolism, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Buckinghamshire Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 26 Sep 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.
Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes are treated with a "basal bolus" insulin regimen, with background insulin provided by long-acting "basal" insulin doses, and "bolus" doses of short-acting insulin used to accompany food intake. Evidence shows that the main factor preventing people with diabetes from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A previous study has shown that the type of background insulin affects the likelihood of an individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards. The aim of this study is to examine this further.
The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with insulin glargine than insulin detemir. Exercise intensity can have an influence on the likelihood of hypoglycaemia, and in this previous study exercise intensity was measured using heart rate. This study will use a more formal definition of exercise intensity. The investigators will study blood glucose during exercise, but also metabolism as measured by hormones affecting blood glucose levels as well as markers of fat metabolism. The investigators will also use a continuous glucose monitoring system (CGMS) to consider hypoglycaemia on thei night following exercise as this is a recognised consequence of exercise in type 1 diabetes.
The null hypothesis to be tested in this study is that there is no difference between the two insulins in their effect on blood glucose levels and metabolism during exercise and rates of nocturnal hypoglycaemia after exercise.
Detailed description
A1: At the first appointment, potential participants will be screened regarding the inclusion criteria, and if eligible to take part the study information sheet will be discussed with them in detail. Written, informed consent will be obtained if participants are willing to take part in the study. Participants will be given advice and support from this point in order to optimise basal insulin therapy using their usual basal insulin.
A2: Following a period of at least 3 weeks from recruitment into the study, participants will have their maximal oxygen uptake (VO2 MAX - a measure of capacity for physical exercise) assessed.
A3: After at least 4 weeks following recruitment , to allow time for optimisation of basal insulin therapy, and at least one week following A2, the participant's metabolism will then be assessed during and after 60 minutes of exercise at 50% VO2 MAX. Participants will be fitted with a continuous glucose monitoring system (CGMS) to monitor glucose levels for the 24 hours after exercise finishes.
A4: At least 24 hours and no more than 7 days after A3 the participant will switched to using the other trial insulin for basal insulin therapy. Again, participants will be provided with advice and support in order to optimise treatment.
A5: At least 4 weeks following A4, the participant's metabolism will once again be assessed during and after 60 minutes of exercise at 50% VO2 MAX. Participants will again be fitted with CGMS to monitor glucose levels for the 24 hours after exercise finishes.
A6: Once the 24 hours after exercise are complete, the study finishes and participants re-start their usual basal insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir | Active comparator | Drug: Insulin detemirMetabolism during and after submaximal exercise during treatment with insulin detemir |
| Insulin glargine | Active comparator | Drug: Insulin glargineMetabolism during and after submaximal exercise during treatment with insulin glargine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 Diabetes Mellitus (T1DM)
- HbA1c < 10% or 86 mmol/mol
- Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin
Key exclusion criteria (14 listed)
- People with any one of the following complications of diabetes:
- Pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
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 glargineAlso: LantusUse of insulin glargine as basal insulin for treatment of Type 1 Diabetes Mellitus | Drug | Insulin glargine |
| Insulin detemirAlso: LevemirUse of insulin detemir as basal insulin for treatment of Type 1 Diabetes Mellitus | Drug | Insulin detemir |
Primary outcome
Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise)
Time frame: Between baseline and 1 hour
The measure will be a comparison between the two conditions (treatment with insulin detemir or treatment with insulin glargine) of the change in blood glucose levels during one hour of sub-maximal exercise at 50% VO2 MAX
13 secondary outcomes
Lactate
Time frame: 0, 60 and 90 minutes
NEFA (Non-esterified fatty acids)
Time frame: 0, 60 and 90 minutes
B-OHB (beta-hydroxybutyrate)
Time frame: 0, 60 and 90 minutes
Catecholamines
Time frame: 0, 60 and 90 minutes
Glucagon
Time frame: 0, 60 and 90 minutes
Human growth hormone (hGH)
Time frame: 0, 60 and 90 minutes
Cortisol
Time frame: 0, 60 and 90 minutes
IL-6 (interleukin 6)
Time frame: 0, 60 and 90 minutes
High sensitivity CRP (Hs-CRP)
Time frame: 0, 60 and 90 minutes
RQ (Respiratory Quotient)
Time frame: Baseline and 1 hour
Frequency of hypoglycaemic events
Time frame: 24 hours
Time spent in hypoglycaemia
Time frame: 24 hours
Blood glucose
Time frame: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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.
Ian W Gallen, MD FRCP principal investigator
Bcukinghamshire Healthcare NHS Trust
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 glargine and Insulin detemir in people with Diabetes Mellitus, Type 1, run by Buckinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 14 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 8 Nov 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 United Kingdom. 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?
Contact Alistair N Lumb, MBBS MRCP (+441494425349/+44757007703, sportsdiabetes@hotmail.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise) (time frame: Between baseline and 1 hour). 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 8 Nov 2011.