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Completed

NCT Number: NCT01034111

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

sitagliptin phosphate

Drug

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

Other names: MK-0431, Januvia

metformin

Drug

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

Other names: Glucophage

Primary outcomes

  1. Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose at Week 4

    Time frame: Baseline and Week 4

    Calculated as the mean change from baseline in fasting plasma glucose at Week 4.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2009
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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