Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

NCT00350779 | Completed Phase 3 Results

• 3 other identifiers: 0431-052MK0431-0522006_507
• Study Type: interventional
• Target: 262
• Locations: 0 countries
• Sites: N/A

Brief Summary

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome proliferator-activated receptor gamma (PPARg) agonist combination therapy.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18

  HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent.

  Baseline and 18 Weeks

Secondary Outcomes (5)

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18

  Baseline and 18 Weeks

• Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18

  Baseline and Week 18

• Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54

  Baseline and Week 54

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54

  Baseline and Week 54

• Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54

  Baseline and Week 54

Study Arms (2)

1

EXPERIMENTAL

Sitagliptin

Drug: sitagliptin; Drug: rosiglitazone; Drug: metformin; Drug: glipizide

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo; Drug: rosiglitazone; Drug: metformin; Drug: glipizide

Interventions

sitagliptin DRUG

Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.

Also known as: Januvia

1

Comparator: Placebo DRUG

Placebo to sitagliptin 100mg tablet each day for 54 weeks.

2

rosiglitazone DRUG

Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.

Also known as: Avandia

1; 2

metformin DRUG

Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.

1; 2

glipizide DRUG

Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)

Also known as: Glucotrol

1; 2

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has type 2 diabetes mellitus
• Patient is inadequately controlled while taking two oral antidiabetic medications

You may not qualify if:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
• Patient required insulin therapy within the prior 3 months
• Patient has been taking Byetta (R) (exenatide) within the prior 3 months

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Dobs AS, Goldstein BJ, Aschner P, Horton ES, Umpierrez GE, Duran L, Hill JS, Chen Y, Golm GT, Langdon RB, Williams-Herman DE, Kaufman KD, Amatruda JM, Ferreira JC. Efficacy and safety of sitagliptin added to ongoing metformin and rosiglitazone combination therapy in a randomized placebo-controlled 54-week trial in patients with type 2 diabetes. J Diabetes. 2013 Mar;5(1):68-79. doi: 10.1111/j.1753-0407.2012.00223.x.

  PMID: 22742523 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Rosiglitazone; Metformin; Glipizide

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; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Biguanides; Guanidines; Amidines; Sulfonylurea Compounds; Sulfones

Limitations and Caveats

Non-serious adverse event results represent those events included in the primary safety analysis for this study (events occurred prior to initiation of glycemic rescue therapy). Site 0520039 was non-compliant with GDP, data was removed from analyses.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclsoure@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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2006
• First Posted: July 11, 2006
• Study Start: June 12, 2006
• Primary Completion: September 25, 2007
• Study Completion: June 11, 2008
• Last Updated: May 12, 2017
• Results First Posted: July 3, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share