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Register:	EUCTR
Last refreshed on:	18 April 2012
Main ID:	EUCTR2008-003640-11-BG
Date of registration:	10/03/2009
Prospective Registration:	No
Primary sponsor:	Merck & Co., Inc.
Public title:	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
Scientific title:	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:	09/03/2009
Target sample size:	1295
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003640-11
Study type:	Interventional clinical trial of medicinal product
Study design:	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
Phase:

Countries of recruitment
Austria	Bulgaria	Estonia	Greece	Italy	Latvia	Lithuania	Slovenia

Contacts

Name:
Address:
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Affiliation:

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Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

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

Primary Outcome(s)

Main Objective: To assess HbA1c after 24 weeks

Primary end point(s): HbA1c; Safety

Secondary Objective: To assess FPG and PPG after 24 weeeks. To assess HbA1c, FPG, PPG and Safety after 54 weeks.

Secondary Outcome(s)

Secondary ID(s)

0431C-102

2008-003640-11-IT

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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