Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Sitagliptin phosphate (Drug); Comparator: Placebo (Drug); Acarbose (Drug); Glimepiride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will evaluate whether the addition of sitagliptin reduces hemoglobin A1C (A1C)
more than the addition of placebo for participants with type 2 diabetes mellitus (T2DM) on a
steady dose of acarbose. The primary hypothesis is that the addition of sitagliptin 100 mg
once daily (q. d.) reduces A1C more than the addition of placebo in participants with T2DM
with inadequate glycemic control on acarbose monotherapy.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Hemoglobin A1c (A1C) at Week 24Number of Participants Who Experienced at Least One Adverse Event Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Secondary outcome: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Detailed description:
The study includes an 8-week antihyperglycemic agent (AHA) wash-off period* (which includes
a 2-week single-blind placebo run-in period) followed by a 24-week double-blind treatment
period. All participants will receive open-label acarbose at a minimum dose of 50 mg three
times daily (t. i.d.) during the run-in and treatment periods.
*: Wash-off only applicable to patients who were on acarbose and another AHA.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 thiazolidinedione (TZD), 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
Locations and Contacts
Additional Information
Starting date: January 2011
Last updated: February 9, 2015
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