A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

NCT01034111 | Completed Phase 3 Results

• 2 other identifiers: 0431-1782009_705
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment

  Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.

  4 weeks

Secondary Outcomes (1)

• Change From Baseline in Fasting Plasma Glucose at Week 4

  Baseline and Week 4

Study Arms (1)

Sitagliptin

EXPERIMENTAL

Sitagliptin as add-on therapy to a stable dose of metformin

Drug: Sitagliptin phosphate; Drug: Metformin

Interventions

Sitagliptin phosphate DRUG

Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.

Also known as: MK-0431, Januvia

Sitagliptin

Metformin DRUG

Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.

Also known as: Glucophage

Sitagliptin

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with T2DM failing metformin monotherapy
• Between the ages of 18 and 79

You may not qualify if:

• Participants has a history of type 1 Diabetes Mellitus or ketoacidosis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin

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; Biguanides; Guanidines; Amidines; Organic Chemicals

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: March 1, 2010
• Primary Completion: October 4, 2010
• Study Completion: October 4, 2010
• Last Updated: May 30, 2017
• Results First Posted: November 7, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share