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Completed

NCT Number: NCT00350779

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Sitagliptin

Drug

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

Other names: Januvia

Comparator: placebo

Drug

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

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.

Other names: Avandia

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.

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.)

Other names: Glucotrol

Primary outcomes

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

    Time frame: Baseline and 18 Weeks

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

Secondary outcomes

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

    Time frame: Baseline and 18 Weeks

    Change from baseline at Week 18 is defined as Week 18 minus Week 0

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

    Time frame: Baseline and Week 18

    Change from baseline at Week 18 is defined as Week 18 minus Week 0

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

    Time frame: Baseline and Week 54

    HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.

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

    Time frame: Baseline and Week 54

    Change from baseline at Week 54 is defined as Week 54 minus Week 0

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

    Time frame: Baseline and Week 54

    Change from baseline at Week 54 is defined as Week 54 minus Week 0.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Metformin and a PPARg Agonist

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 11, 2006
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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