Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

• ClinicalTrials.gov Identifier: NCT00086515
• Recruitment Status: Completed
• First Posted: July 5, 2004
• Results First Posted: December 17, 2010
• Last Update Posted: May 5, 2017
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type II	Drug: Sitagliptin (MK0431); Drug: Placebo/Glipizide 5 mg; Drug: Metformin; Drug: Pioglitazone	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 701 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
• Actual Study Start Date: June 30, 2004
• Actual Primary Completion Date: July 20, 2005
• Actual Study Completion Date: February 2, 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sitagliptin 100 mg; The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.	Drug: Sitagliptin (MK0431); Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104; Other Names: MK0431; sitagliptin phosphate; Januvia; Drug: Metformin; Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104); Drug: Pioglitazone; Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24); Other Name: ACTOS
Placebo Comparator: Placebo / Glipizide 5 mg; The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.	Drug: Placebo/Glipizide 5 mg; Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104); Drug: Metformin; Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104); Drug: Pioglitazone; Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24); Other Name: ACTOS

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and 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.

Secondary Outcome Measures :

1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]

   Change from baseline at Week 24 is defined as FPG at

   Week 24 minus FPG at Week 0.

2. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ]
   Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 78 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme LLC

More Information

Study Data/Documents: CSR Synopsis 

Publications:

Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706.

Xu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT00086515
• Other Study ID Numbers: 0431-020; Formally-B0604T2DMT; 2006_411
• First Posted: July 5, 2004
• Results First Posted: December 17, 2010
• Last Update Posted: May 5, 2017
• Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme LLC:

Type 2 Diabetes Mellitus

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Pioglitazone; Sitagliptin Phosphate; Glipizide; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action