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

NCT00545584 | Completed Phase 3 Results

• 2 other identifiers: 0431-0782007_023
• Study Type: interventional
• Target: 1,512
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c Measurement

  Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.

  Baseline and Week 24

Secondary Outcomes (1)

• Fasting Plasma Glucose (FPG) Measurement

  Baseline and Week 24

Study Arms (3)

Sitagliptin with Standard of Care

EXPERIMENTAL

Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.

Drug: sitagliptin phosphate

Sitagliptin with Diet Advice

EXPERIMENTAL

Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary

Drug: sitagliptin phosphate; Behavioral: Comparator: Diet

Sitagliptin with Diet and Physical Activity Advice

EXPERIMENTAL

Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Drug: sitagliptin phosphate; Behavioral: Comparator: Diet; Behavioral: Comparator: Physical Activity

Interventions

sitagliptin phosphate DRUG

sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks

Sitagliptin with Diet Advice; Sitagliptin with Diet and Physical Activity Advice; Sitagliptin with Standard of Care

Comparator: Diet BEHAVIORAL

Diet

Sitagliptin with Diet Advice; Sitagliptin with Diet and Physical Activity Advice

Comparator: Physical Activity BEHAVIORAL

Physical Activity

Sitagliptin with Diet and Physical Activity Advice

Eligibility Criteria

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

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

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

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: April 1, 2007
• Primary Completion: November 19, 2009
• Study Completion: November 19, 2009
• Last Updated: May 12, 2017
• Results First Posted: May 11, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share