Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

NCT00087516 | Completed Phase 3 Results

• 4 other identifiers: 0431-021Formally-C0604MT2DMK0431-0212006_413
• Study Type: interventional
• Target: 741
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 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.

  Weeks 0-24

Secondary Outcomes (5)

• Change From Baseline in FPG at Week 24

  Weeks 0-24

• Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24

  Weeks 0-24

• Change From Baseline in A1C at Week 104

  Weeks 0-104

• Change From Baseline in FPG at Week 104

  Weeks 0-104

• Change From Baseline in 2-hr PMG at Week 104

  Weeks 0-104

Study Arms (4)

Sitagliptin 100 mg/100 mg

ACTIVE COMPARATOR

Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )

Drug: Sitagliptin (MK0431); Drug: Metformin - Rescue

Sitagliptin 200 mg/200 mg

ACTIVE COMPARATOR

Phase A and B: Oral tablets of sitagliptin 200 mg q.d

Drug: Sitagliptin; Drug: Metformin - Rescue

Placebo/Sitagliptin 100 mg

PLACEBO COMPARATOR

Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.

Drug: Placebo; Drug: Metformin - Rescue

Placebo/Sitagliptin 200 mg

PLACEBO COMPARATOR

Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

Drug: Placebo; Drug: Metformin - Rescue

Interventions

Sitagliptin (MK0431) DRUG

Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Also known as: MK0431, Januvia

Sitagliptin 100 mg/100 mg

Sitagliptin DRUG

Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.

Also known as: MK0431, Januvia

Sitagliptin 200 mg/200 mg

Placebo DRUG

Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.

Placebo/Sitagliptin 100 mg

Metformin - Rescue DRUG

Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Also known as: Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet

Placebo/Sitagliptin 100 mg; Placebo/Sitagliptin 200 mg; Sitagliptin 100 mg/100 mg; Sitagliptin 200 mg/200 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes mellitus
• Patient is not pregnant or breastfeeding
• Male or female patient unlikely to conceive
• Patient not on an antihyperglycemic drug

You may not qualify if:

• Patient has history of type 1 diabetes mellitus
• Patient has history of ketoacidosis
• Patient requires insulin within 8 weeks prior to start of study
• Patient on weight loss program and is not in maintenance phase
• Patient taking weight loss medication within 8 weeks prior to start of study
• Patient on or likely to require = 14 days or repeated courses of corticosteroids
• Patient taking immunosuppressive/immunomodulating medication
• Patient taking digoxin or other cardiac medication
• Patient has undergone surgical general anesthesia within 30 days prior to start of study
• Patient taking investigational drug within 8 weeks prior to start of study
• Patient is diagnosed with liver disease
• Patient has chronic myopathy, progressive neurological/neuromuscular disorder
• Patient has with severe cardiac conditions within the last 6 months
• Patient is Human immunodeficiency virus (HIV) positive
• Patient has hematological disorder

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.

  PMID: 17130196 BACKGROUND

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

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: July 9, 2004
• First Posted: July 13, 2004
• Study Start: June 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: February 1, 2007
• Last Updated: July 3, 2015
• Results First Posted: June 8, 2010

Record last verified: 2015-06