NCT00862875

Brief 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 and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

5.1 years

First QC Date

March 16, 2009

Last Update Submit

May 6, 2014

Conditions

Type 2 Diabetes

Keywords

Insulin initiationoral therapy failure

Outcome Measures

Primary Outcomes (1)

  • Changes in total fat mass (in kg)

    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.

    Baseline and 6 months

Study Arms (2)

1:Insulin detemir

EXPERIMENTAL

Insulin detemir (Levemir® - Novolin® 4 pen)

Drug: Detemir or Glargine

2:Insulin Glargin

ACTIVE COMPARATOR

Insulin glargine (Lantus® - Solostar®)

Drug: Detemir or Glargine

Interventions

Detemir or GlargineDRUG

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.

Also known as: Detemir, Levemir, Long acting insulin, Bed time insulin, Lantus, basal insulin analogue
1:Insulin detemir2:Insulin Glargin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin DetemirInsulin GlargineInsulin, Long-Acting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

InsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Remi Rabasa-Lhoret, MD, PhD

    Institut de recherches cliniques de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2014

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

CA(1)