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

Purpose

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

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Glipizide Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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:

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.
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.


Enrollment:	701
Actual Study Start Date:	June 30, 2004
Study Completion Date:	February 2, 2007
Primary Completion Date:	July 20, 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


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

Criteria

Inclusion Criteria:

Patients with type 2 diabetes mellitus

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086515

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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.

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.

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00086515 History of Changes
Other Study ID Numbers:	0431-020 Formally-B0604T2DMT 2006_411
Study First Received:	July 2, 2004
Results First Received:	November 19, 2010
Last Updated:	March 31, 2017

Keywords provided by Merck Sharp & Dohme Corp.:


Type 2 Diabetes Mellitus

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pioglitazone Metformin 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

ClinicalTrials.gov processed this record on June 26, 2017