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COMPLETEDPHASE3

Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

NCT00545584•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Man or woman aged \>/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Exclusion Criteria

•Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
•Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
•Known hypersensitivity or contraindication to metformin

Key Dates

Start Date

April 1, 2007

Primary Completion Date

November 19, 2009

Completion Date

November 19, 2009

Last Updated

May 12, 2017

Enrollment

1,512

ACTUAL participants

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Interventions

sitagliptin phosphate

DRUG

Comparator: Diet

BEHAVIORAL

Comparator: Physical Activity

BEHAVIORAL

Technology Intensified Diabetes Education Study in African Americans

NCT02088658

Diabetes Mellitus, Type 2Diabetes Mellitus, Adult-Onset+3 more

View study

COMPLETEDPHASE1

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

NCT02113163

Diabetes Mellitus, Non-Insulin-DependentHypertriglyceridemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Inclusion Criteria

Exclusion Criteria

Technology Intensified Diabetes Education Study in African Americans

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

Diabetes Prevention Program

Effect of Gelofusine on GLP1-receptor Imaging

A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea