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Main
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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: |
EUCTR2009-009500-39-DE |
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Date of registration:
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06/05/2009 |
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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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A Randomized Trial Comparing two therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects with Type 2 Diabetes who were previously treated by basal insulin Glargine with either Metformin or Metformin and Sulfonylurea - GWDM |
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Date of first enrolment:
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14/04/2010 |
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Target sample size:
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760 |
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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:2009-009500-39 |
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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: no
Other: no
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Phase:
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Countries of recruitment
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Estonia
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Finland
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France
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Germany
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Greece
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Italy
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Netherlands
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Portugal
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Spain
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Sweden
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
[1]Have T2DM (as defined by World Health Organization [WHO] classification)
[2]Are at least 18 years of age
[3]Have been taking a basal insulin Glargine, at dose of =20 units/day, for at least 3 months prior to visit 1
[4]Have been taking basal insulin Glargine at dose of =20 units/day, in combination with 1 of the following OAM regimens, for at least 3 months prior to visit 1
[a]Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to visit 1.
Or
[b]Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to visit 1 and sulfonylurea at a stable dose for 6 weeks prior to visit 1.
[5]Have an HbA1C >7.0% and =10.0%.
[6]Have a body mass index (BMI) between =25 and =45 kg/m2.
[7]Have a history of stable body weight (not varying by >10% for at least 3 months prior to visit 1.
[8]Liver enzyme tests (alanine aminotransferase [ALT]; aspartate aminotransferase [AST]) are not greater than three times of the upper limit of the reference range (as defined by the Lilly-designated laboratory).
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:
[9]Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label
[10] Have taken more than 1 week within 1 month prior to the visit 1 any glucose-lowering medications not included in inclusion criteria [3] and [4]
[11]Have taken any insulin other than Glargine within the 3 months prior to visit 1 for more than 1 week.
[12]Are receiving chronic systemic glucocorticoid therapy within 4 weeks prior to the visit 1
[13] Have had a clinically significant history of cardiac disease with functional status that is Class III or IV or considered by the investigator to be exclusionary.
[14]Have had more than 1 episode of major hypoglycemia, as defined in the Abbreviations and Definitions section, within 6 months prior to visit 1
[15]Female subjects with a positive pregnancy test and/or intending to become pregnant or sexually active and not using birth control throughout the study to prevent pregnancy.
[16]Women who are breastfeeding.
[17]Have any of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic or gastrointestinal disease or any other serious disease considered by the investigator to be exclusionary.
[18]Have fasting triglycerides levels > 500mg/dl ( >5.64mmol/l)
[19]Have a history of renal transplantation or are currently receiving renal dialysis.
[20]Have a history of confirmed pancreatitis
[21]Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
[22]Have contraindication or known hypersensitivity or allergy to Exenatide or to any of the product components (including prior withdrawal of Exenatide therapy after experiencing adverse events).
[23] Have had a blood transfusion or severe blood loss within 3 months prior to visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other condition known to interfere with the HbA1c methodology.
[24] Have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes the subject from following and completing the protocol, according to the investigator’s judgment.
[25] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[26] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[27]Are employed by Lilly or Amylin Pharmaceuticals, Inc. (Amylin)
[28]Have previously completed or been withdrawn from this study after enrollment.
[29]If on metformin and have contraindication to metformin use, including known metabolic or lactic acidosis, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
[30]Have had a radiologic contrast study performed within 48 hours prior to visit 1.
[31] have any exclusion required by local law
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes
MedDRA version: 9.1
Level: LLT
Classification code 10012594
Term: Diabetes
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Intervention(s)
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Trade Name: Byetta
Pharmaceutical Form: Solution for injection
INN or Proposed INN: exenatide
CAS Number: 141732-76-5
Current Sponsor code: LY2148568, AC 2993
Other descriptive name: exendin-4, exendin 4, exenatide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Byetta
Pharmaceutical Form: Solution for injection
INN or Proposed INN: exenatide
CAS Number: 141732-76-5
Current Sponsor code: LY2148568, AC 2993
Other descriptive name: exendin-4, exendin 4, exenatide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Humalog
Product Name: insulin lispro
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin lispro
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Product Name: metforminhydrochlorid
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: metforminhydrochlorid
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: metforminhydrochlorid
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: metforminhydrochlorid
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Product Name: metforminhydrochlorid
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: metforminhydrochlorid
CAS Number: 657-24-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Lantus
Product Name: Insulin glargin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
CAS Number: 160337-95-1
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: To compare the efficacy and safety between the BET and BBT regimens with respect to:
•Percentage of subjects with HbA1C =7.0 % with minimum weight gain and with HbA1C =6.5 % with minimum weight gain (=1kg)
• Percent of subjects with HbA1c =7.0 % and =6.5 %
• FBG
•7-point self-monitored blood glucose (SMBG) profiles and daily mean blood glucose (BG) based on the 7-point SMBG profile
•Fasting Glucagon
•Total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
•Body weight and BMI
•Waist and hip circumference
•Insulin dose
• SBP and DBP
• Safety as measured by
o self-reported hypoglycemic episodes and incidence of major hypoglycemic events
oTEAEs
oanti-Exenatide antibodies
•Patient reported quality of life as measured by the short form of the IWQOL-Lite
• Patient satisfaction with treatment as measured by the DTSQ) status and change versions
•Resource use with regards to Adverse Events and frequency of non-protocol required SMBG.
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Main Objective: To estimate the difference in change in HbA1c from the randomization visit (visit 2) to endpoint (30 weeks) between 2 regimens: BET (basal insulin Glargine, Exenatide BID and metformin) and BBT (basal insulin Glargine,, bolus insulin insulin TID and metformin) in subjects with type 2 diabetes and inadequate glycemic control (HbA1c > 7.0%) pretreated with basal insulin Glargine in combination with metformin or in combination with metformin and sulfonylurea (SU).
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Primary end point(s): The primary efficacy measure will be the change in HbA1c from baseline (Visit 2) to 30 weeks.
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Secondary ID(s)
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2009-009500-39-FR
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H8O-EW-GWDM
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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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