Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130 AM1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01177384

First received: June 30, 2010

Last updated: April 18, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2010

Last Updated Date

April 18, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in A1C at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01177384 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and week 24 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130 AM1)

Official Title ^ICMJE

A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Acarbose Monotherapy

Brief Summary

This study will evaluate whether the addition of Sitagliptin reduces Hemoglobin A1C more than the addition of placebo for patients with type 2 Diabetes Mellitus on a steady dose of acarbose.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: sitagliptin phosphate
Sitagliptin, 100 mg tablet once daily, orally for 24 weeks

Other Name: Januvia
Drug: Comparator: Placebo
Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks
Drug: Comparator: Acarbose
Acarbose 50 mg or 100 mg tablet, 3 times daily, orally for 24 weeks

Other Name: Precose

Study Arm (s)

Experimental: Sitagliptin
Acarbose + Sitagliptin phosphate 100 mg
Interventions:
- Drug: sitagliptin phosphate
- Drug: Comparator: Acarbose
Placebo Comparator: Placebo
Acarbose + Placebo
Interventions:
- Drug: Comparator: Placebo
- Drug: Comparator: Acarbose

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

393

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

has T2DM and is on acarbose alone at a stable dose of at least 50 mg t.i.d.(three times a day) for at least 10 weeks or on acarbose at a stable dose of at least 50 mg t.i.d. (three times a day) for at least 10 weeks in combination with another antihyperglycemic agent (AHA)
is at least 18 years of age (for participants in India: between 18 and 65 years of age)
male or female who is unlikely to conceive (not of reproductive potential, or agrees to remain abstinent or use [or have partner use] acceptable birth control if of reproductive potential)

Exclusion Criteria:

has a history of type 1 diabetes mellitus
use of dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, or insulin
has the following cardiovascular disorders: acute coronary syndrome; new or worsening symptoms of coronary heart disease; coronary artery intervention; stroke or transient ischemic neurological disorder
has liver or kidney disease
has cancer or any clinically significant disease or disorder as judged by the Investigator

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01177384

Other Study ID Numbers ^ICMJE

0431-130, 2010_543

Has Data Monitoring Committee

Responsible Party

Merck

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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