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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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30 June 2019 |
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Main ID: |
EUCTR2004-000867-92-GB |
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Date of registration:
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24/02/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Multicenter, Randomized, Double-Blind Study of MK-0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - MK-0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus
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Scientific title:
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A Multicenter, Randomized, Double-Blind Study of MK-0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control - MK-0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus |
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Date of first enrolment:
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06/01/2005 |
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Target sample size:
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500 |
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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:2004-000867-92 |
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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: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Hungary
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Lithuania
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
a. Patient has type 2 diabetes mellitus.
b. Patient is =18 to =75 years of age.
c. Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
d. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period.
e. Patient is a male, or a female who is highly unlikely to conceive.
f. HbA1C =7% and =10% measured at or within 2 weeks prior to Visit 3.
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:
a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
b. Patient has an ALT or AST >2.0-fold the upper limit of normal (ULN).
c. Patient’s renal function is reflected below as indicated by a “yes” answer to one of the following:
1) Patient is a male =65 years of age and serum creatinine >1.8 mg/dL (159.1 µmol/L).
2) Patient is a female =65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
3) Patient is a male >65 years of age and serum creatinine >1.6 mg/dL (141.4 µmol/L).
4) Patient is a female >65 years of age and serum creatinine >1.3 mg/dL (114.9 µmol/L).
5) Creatinine clearance is <50 mL/min.
d. Patient has any of the following disorders within the past 6 months:
• Acute coronary syndrome (e.g., MI or unstable angina).
• Coronary artery intervention (e.g., CABG or PTCA).
• Worsening congestive heart failure (e.g., worsening symptoms or increase in pharmacologic therapy).
• Stroke or transient ischemic neurological disorder.
e. Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months.
f. Patient has a BMI <20 kg/m2 or >43 kg/m2.
g. Patient has a positive urine pregnancy test.
h. Patient has any other condition or therapy which, in the opinion of the investigator or Merck medical monitor, might pose a risk to the patient or make participation not in the patient’s best interest.
i. Patient has poor mental function or there is any other reason to expect that they may have difficulty in complying with the requirements of 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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Type 2 Diabetes Mellitus
MedDRA version: 7.0
Level: LLT
Classification code 10045242
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Intervention(s)
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Product Name: MK-0431
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0431
Other descriptive name: L-000224715
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 [pioglitzone HCL]
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Other descriptive name: ACTOS
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
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Primary Outcome(s)
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Main Objective: Main objective : In patients with type 2 diabetes mellitus with inadequate glycemic control on diet and exercise: (1) After 18 weeks, to assess the effect of treatment with MK-0431 compared with placebo on HbA1C; (2) To assess the safety and tolerability of MK-0431.
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Secondary Objective: Secondary objectives : After 18 weeks, to assess the effect of treatment with MK-0431 compared with placebo on: (1) fasting plasma glucose (FPG) and fructosamine; (2) the proportion of patients needing glycemic rescue medication; (3) In a subset of patients undergoing a meal tolerance test: indices of insulin secretion derived from the C-peptide, insulin, and glucose profiles; and glucagon; Over 54 weeks, to assess the effect of treatment with MK-0431 on: (4) HbA1C and FPG; (5) the durability of glycemic efficacy; (6) In a subset of patients undergoing a meal tolerance test: indices of insulin secretion derived from C-peptide, insulin, and glucose profiles; and glucagon.
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Primary end point(s): HbA1c
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Secondary ID(s)
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0431-023
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2004-000867-92-HU
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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