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Completed

NCT Number: NCT00701090

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

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Key information

Conditions

Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

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

  • 18 years or older
  • Diagnosed with type 2 diabetes
  • On a stable dose of metformin of at least 1500 mg per day

Exclusion criteria

  • History of type 1 diabetes
  • Pregnant
  • HIV positive
  • On a weight loss program or medication
  • Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Treatment and study plan

Sitagliptin

Drug

Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks

Other names: Januvia

Comparator: glimepiride

Drug

glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.

open-label metformin

Drug

open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.

Other names: metformin

Primary outcomes

  1. Change From Baseline in HbA1c at Week 30

    Time frame: Week 0 to Week 30

    Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.

Secondary outcomes

  1. Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30

    Time frame: Week 0 to Week 30

    Change from baseline at Week 30 was defined as Week 30 minus Week 0.

  2. Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30

    Time frame: Week 0 to Week 30

  3. Change From Baseline in Body Weight at Week 30

    Time frame: Week 0 to Week 30

    Change from baseline at Week 30 was defined as Week 30 minus Week 0.

  4. Percent of Patients With A1C <7.0% at Week 30

    Time frame: Week 30

  5. Percent of Patients With A1C <6.5% at Week 30

    Time frame: Week 30

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2008
Registry last updated
Mar 10, 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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