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)

NCT01177384 | Completed Phase 3 Results DMC

• 3 other identifiers: 0431-1302010_543CTRI/2011/10/002072
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; T2DM

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24

  A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.

  Baseline and Week 24

• Number of Participants Who Experienced at Least One Adverse Event

  Up to Week 24 + 14 Day Post-Study Follow-up

• Number of Participants Who Discontinued Study Drug Due to an Adverse Event

  Up to 24 Weeks

Secondary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])

Drug: Sitagliptin phosphate; Drug: Acarbose; Drug: Glimepiride

Placebo

PLACEBO COMPARATOR

Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)

Drug: Comparator: Placebo; Drug: Acarbose; Drug: Glimepiride

Interventions

Sitagliptin phosphate DRUG

Sitagliptin, 100 mg tablet once daily, orally for 24 weeks

Also known as: Januvia

Sitagliptin

Comparator: Placebo DRUG

Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks

Placebo

Acarbose DRUG

Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks

Also known as: Precose

Placebo; Sitagliptin

Glimepiride DRUG

Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.

Also known as: Amaryl®, Glimy

Placebo; Sitagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Wang W, Ning G, Ma J, Liu X, Zheng S, Wu F, Xu L, O'Neill EA, Fujita KP, Engel SS, Kaufman KD, Shankar RR. A randomized clinical trial of the safety and efficacy of sitagliptin in patients with type 2 diabetes mellitus inadequately controlled by acarbose alone. Curr Med Res Opin. 2017 Apr;33(4):693-699. doi: 10.1080/03007995.2016.1277200. Epub 2017 Jan 25.

  PMID: 28035868 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Acarbose; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: August 9, 2010
• Study Start: January 25, 2011
• Primary Completion: March 25, 2013
• Study Completion: March 25, 2013
• Last Updated: August 16, 2018
• Results First Posted: April 28, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share