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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2007-006640-22-IT |
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Date of registration:
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22/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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Superiority of insulin glargine Lantus vs. NPH ''Treat to Normoglycemia concept''.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naive People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - ND |
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Date of first enrolment:
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29/04/2009 |
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Target sample size:
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670 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006640-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo:
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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France
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Italy
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Netherlands
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Poland
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Spain
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Aged from 30 to 70 years inclusively Insulin-naïve type 2 diabetes mellitus (T2DM) T2DM diagnosed for at least 1 year Treated with at least one OAD at stable dose for at least 3 months: monotherapy or combination must include metformin (daily dose 1700 mg) unless being contra-indicated or poorly tolerated HbA1c 7.0% and <9.0% BMI < 40 kg/m2 Ability and willingness to perform plasma glucose monitoring Sponsor-provided glucose meter and patient diary at home Informed consent obtained in writing at enrolment into the study Willingness and ability to comply with the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Treatment with GLP-1 agonists in the 3 months prior to study entry Treatment with DPP-IV inhibitors in the 3 months prior to study entry Diabetes mellitus other than Type 2 Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry) Impaired renal function: serum creatinine ≥1.5 mg/dL (≥133µmol/L) or ≥1.4 mg/dL (≥124 µmol/L) in men and women, respectively History of sensitivity to the study drugs or to drugs with a similar chemical structure Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range) Pregnancy or breastfeeding Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted. Treatment with an investigational product in the 30 days prior to visit 1 Alcohol or drug abuse in the last year Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient?s safety or limit the patient successful participation in the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with type 2 diabetes mellitus (T2DM) insulin-naïve diagnosed by at least one year and in treatment with at least one oral hypoglycaemic at a dose stable for at least 3 months: monotherapy or combination must include metformin (daily dose of at least 1700 mg) unless it is just tolerated or contraindicated
MedDRA version: 9.1
Level: LLT
Classification code 10049746
Term: Insulin-requiring type II diabetes mellitus
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Intervention(s)
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Trade Name: LANTUS*SOLOST.SC 5PEN 100UI/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
Concentration type: equal
Trade Name: INSUMAN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin (human)
Concentration unit: U unit(s)
Concentration type: equal
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Primary Outcome(s)
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Primary end point(s): The primary endpoint will be the change in HbA1c from baseline to end of study treatment in the intent-to-treat (ITT) population.
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Secondary Objective: To compare between treatment groups: - Plasma glucose (fasting, nocturnal) over time, - Changes from baseline in HbA1c over time, - Percentage of patients who reach the target of HbA1c <7% and <6.5%, - Use of prandial insulin as rescue medication at month 6, - Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), - Daily dose of insulin, - Change in body weight from baseline, - Evolution of 8-point plasma-glucose (PG) profiles, - Overall safety, - Patient reported outcomes (treatment satisfaction).
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Main Objective: To demonstrate the superiority of insulin glargine over insulin NPH on the change in HbA1c from baseline to the end of the treatment period.
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Secondary ID(s)
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LANTU_C_02762
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2007-006640-22-ES
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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