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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. |
Register:
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EUCTR |
Last refreshed on:
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18 April 2012 |
Main ID: |
EUCTR2008-003640-11-EE |
Date of registration:
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22/12/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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Scientific title:
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A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
Date of first enrolment:
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12/02/2009 |
Target sample size:
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1295 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003640-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
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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Austria
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Bulgaria
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Estonia
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Greece
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Italy
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Latvia
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Lithuania
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Slovenia
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient is highly unlikely to conceive. Patient is naive to all AHA therapies, off AHA therapies for =8 weeks, or on metformin or sulfonylurea monotherapy. Patient has T2DM.and is =18 and =78 years of age on day of signing informed consent. 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: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. Patient has previously been treated with insulin, TZD (rosiglitazone or pioglitazone), any DPP-4 inhitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic. Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks. Patient has undergone surgery within the prior 30 days or has major surgery planned during the study. Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis. Exclusion of patients who have fasting glucose >270 mg/dL (as determined either by fingerstick or FPG) occurring 2 times or more over a 72-hour period in patients undergoing AHA wash-off. The maximum permitted screening HbA1c for patients undergoing wash-off of metformin or sulfonylurea monotherapy is 9.0%.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus MedDRA version: 9.1
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
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Intervention(s)
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Trade Name: Januvia Product Name: Januvia Pharmaceutical Form: Tablet INN or Proposed INN: sitagliptin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: ACTOS Product Name: ACTOS Pharmaceutical Form: Tablet INN or Proposed INN: pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: ACTOS Product Name: ACTOS Pharmaceutical Form: Tablet INN or Proposed INN: pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: ACTOS Product Name: ACTOS Pharmaceutical Form: Tablet INN or Proposed INN: pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To assess HbA1c after 24 weeks
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Secondary Objective: To assess FPG and PPG after 24 weeeks. To assess HbA1c, FPG, PPG and Safety after 54 weeks.
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Primary end point(s): HbA1c; Safety
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Secondary ID(s)
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0431C-102
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2008-003640-11-IT
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Source(s) of Monetary Support
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Results
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Results available:
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