Type 2 DiabetesPhase 4NCT00862875
Levemir-Body Composition and Energy Metabolism
A Phase 4 study testing Detemir or Glargine in people with Type 2 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Detemir or Glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Apr 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator.
- Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0%
- Stable body weight for previous 3 months (± 5 kg).
- Structured exercise lower than 4 hours per week.
- Metformin ≥1.5 g/day
Who cannot join
- Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
- Type 1 Diabetes Mellitus
- Previous treatment with insulin (< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable.
- Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young
- Proliferative retinopathy/maculopathy requiring treatment
- Hypoglycemia unawareness or recurrent major hypoglycaemia
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- Pregnancy and breast-feeding
- Unstable coronary artery disease
- Heart Failure as defined by class IV according to NYHA classification
- Recent (< 6 months) history of myocardial infarction, stroke or T.I.A, ventricular arrhythmias, or unstable supra-ventricular arrhythmias.
- Renal Insufficiency. Creatinine clearance < 40 ml/min (MDRD formula).
- Acute (< 2 months) or Chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks
- Recent (< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer
- Major psychiatric diseases
- History of drug addiction
- Previous bariatric surgery
- Medication that affects weight such as
- Systemic corticosteroids (prednisone)
- Anti-obesity medication (Xenical® or Meridia®)
- Megace ®
- Antidepressant medication associated with significant weight impact such as Zyprexa®, Remeron® based on investigator judgment.
- Growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment
- Medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
- Conditions
- Type 2 Diabetes
- Being tested
- Detemir or Glargine
- Keywords
- Insulin initiation, oral therapy failure
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detemir or GlargineDrug
Also called Detemir, Levemir, Long acting insulin, Bed time insulin
Initial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L.
| Study group | Role | What they receive |
|---|---|---|
| 1:Insulin detemir | Experimental | Insulin detemir (Levemir® - Novolin® 4 pen) Receives: Drug: Detemir or Glargine |
| 2:Insulin Glargin | Active comparator | Insulin glargine (Lantus® - Solostar®) Receives: Drug: Detemir or Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total fat mass (in kg)
Measured: Baseline and 6 months
Secondary outcomes (1)
Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, McMaster University
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, MD, PhD, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862875
- Sponsor's protocol ID
- RRL-01-2009
- Status last verified
- May 2014
- First submitted
- 16 Mar 2009
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism
- ClinicalTrials.gov ID
- NCT00862875
- Acronym / sponsor ID
- RRL-01-2009
- Conditions
- Type 2 Diabetes
- Keywords
- Insulin initiation, oral therapy failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, McMaster University
- Study start
- Mar 2009
- Primary completion
- Apr 2014 (actual)
- First posted
- 17 Mar 2009 (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.
The objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between Insulin detemir (Levemir® - Novolin® 4 pen) and insulin glargine (Lantus® - Solostar®) both in combination with Metformin and insulin secretagogues (SU) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1:Insulin detemir | Experimental | Drug: Detemir or GlargineInsulin detemir (Levemir® - Novolin® 4 pen) |
| 2:Insulin Glargin | Active comparator | Drug: Detemir or GlargineInsulin glargine (Lantus® - Solostar®) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator.
- Inadequate Glucose control: Hemoglobin A1c (HbA1c) percentage in the range of ≥ 7.5 - 12.0%
- Stable body weight for previous 3 months (± 5 kg).
- Structured exercise lower than 4 hours per week.
- Metformin ≥1.5 g/day
Key exclusion criteria (23 listed)
- Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.
- Type 1 Diabetes Mellitus
- Previous treatment with insulin (< 6 months prior inclusion). Insulin therapy for less than 6 days at the time of an acute event is acceptable.
- Secondary diabetes mellitus (i.e. steroid induced, Cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young
- Proliferative retinopathy/maculopathy requiring treatment
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 |
|---|---|---|
| Detemir or GlargineAlso: Detemir, Levemir, Long acting insulin, Bed time insulinInitial dose of 10 units of insulin at bedtime. The insulin dose will be increase by 1 unit per day until fasting plasma glucose (FPG) levels are 5.0 mmol/L. | Drug | 1:Insulin detemir, 2:Insulin Glargin |
Primary outcome
Changes in total fat mass (in kg)
Time frame: Baseline and 6 months
1 secondary outcome
Epicardial fat, trunk fat, total fat free mass, weight & waist circumference, HbA1c, fasting glucose, RMR, TEF,PAEE & TEE, energy intake.
Time frame: Baseline and 6 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 7 May 2014.
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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.
Remi Rabasa-Lhoret, MD, PhD principal investigator
Institut de Recherches Cliniques de Montreal
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 Detemir or Glargine in people with Type 2 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 5 inclusion and 23 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 May 2014. 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 Canada. 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?
Changes in total fat mass (in kg) (time frame: Baseline and 6 months). 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 May 2014.