Levemir-Body Composition and Energy Metabolism
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ClinicalTrials.gov Identifier: NCT00862875 |
Recruitment Status :
Completed
First Posted : March 17, 2009
Last Update Posted : May 7, 2014
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes | Drug: Detemir or Glargine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Basal Insulin Analogue Detemir on Body Composition, Epicardial Fat and Energy Metabolism |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 1:Insulin detemir
Insulin detemir (Levemir® - Novolin® 4 pen)
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Drug: Detemir or Glargine
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.
Other Names:
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Active Comparator: 2:Insulin Glargin
Insulin glargine (Lantus® - Solostar®)
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Drug: Detemir or Glargine
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.
Other Names:
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- Changes in total fat mass (in kg) [ Time Frame: Baseline and 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862875
Canada, Quebec | |
Institut de Recherches Cliniques de Montréal | |
Montréal, Quebec, Canada, H2W 1R7 |
Principal Investigator: | Remi Rabasa-Lhoret, MD, PhD | Institut de recherches cliniques de Montréal |
Responsible Party: | Rémi Rabasa-Lhoret, MD, PhD, Institut de Recherches Cliniques de Montreal |
ClinicalTrials.gov Identifier: | NCT00862875 |
Other Study ID Numbers: |
RRL-01-2009 |
First Posted: | March 17, 2009 Key Record Dates |
Last Update Posted: | May 7, 2014 |
Last Verified: | May 2014 |
Insulin initiation oral therapy failure |
Insulin Insulin, Globin Zinc Insulin Detemir |
Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs |