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Completed

NCT Number: NCT00481663

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).

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Key information

Conditions

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

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and non-pregnant women
  • Fasting plasma glucose >= 130 mg/dL
  • HbA1c >=6.5% and >10.0%

Exclusion criteria

  • You have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medication
  • You have had surgery within 30 days
  • You hvae hepatitis B or C.

Treatment and study plan

Sitagliptin

Drug

Placebo to Sitagliptin

Drug

metformin

Drug

Rescue

Drug

Patients whose FPG >240 mg/dL from Week 16 or HbA1C >8.5% from Week 25 up to (not including) Week 52 could receive rescue antihyperglycemic therapy with pioglitazone, and remain in the extension study (Extension 1). Participants were eligible for rescue with pioglitazone 30 mg (or rosiglitazone in countries where pioglitazone was not licensed) if they met the following criteria: from Week 16 and during the second extension: FPG consistently >240 mg/dL (repeated and confirmed within 3 to 7 days); from Week 52 up to (not including) Week 70: HbA1C >8%; from Week 70 up to (not including) Visit 21/Week 106: HbA1C >7.5% (Extension 2). Participants placed on rescue therapy with pioglitazone (rosiglitazone where pioglitazone is not available) in the first or second extensions were not eligible for enrollment in the third extension. Rescue therapy was not available in the third extension.

Primary outcomes

  1. Change from Baseline in HbA1C at Week 12

    Time frame: Baseline and Week 12

  2. Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14

    Time frame: Up to Week 14

  3. Number of Participants Who Experienced One or More AE up to Week 54

    Time frame: Up to Week 54

  4. Number of Participants Who Experienced One or More AE up to Week 108

    Time frame: Up to Week 108

  5. Number of Participants Who Experienced One or More AE up to Week 160

    Time frame: Up to Week 160

  6. Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12

    Time frame: Up to Week 12

  7. Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52

    Time frame: Up to Week 52

  8. Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106

    Time frame: Up to Week 106

  9. Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158

    Time frame: Up to Week 158

Secondary outcomes

  1. Change from Baseline in HbA1C at Week 52

    Time frame: Baseline and Week 52

  2. Change from Baseline in HbA1C at Week 106

    Time frame: Baseline and Week 106

  3. Change from Baseline in HbA1C at Week 158

    Time frame: Baseline and Week 158

  4. Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Time frame: Baseline and Week 12

  5. Change from Baseline in FPG at Week 52

    Time frame: Baseline and Week 52

  6. Change from Baseline in FPG at Week 106

    Time frame: Baseline and Week 106

  7. Change from Baseline in FPG at Week 158

    Time frame: Baseline and Week 158

  8. Change from Baseline in Body Weight at Week 12

    Time frame: Baseline and Week 12

  9. Change from Baseline in Body Weight at Week 52

    Time frame: Baseline and Week 52

  10. Change from Baseline in Body Weight at Week 106

    Time frame: Baseline and Week 106

  11. Change from Baseline in Body Weight at Week 158

    Time frame: Baseline and Week 158

  12. Change From Baseline in Serum Fructosamine at Week 12

    Time frame: Baseline and Week 12

  13. Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12

    Time frame: Baseline and Week 12

  14. Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52

    Time frame: Baseline and Week 52

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Finding Study of Once-Daily Dosing of Sitaglipin (MK-0431) in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Important dates

Study start
2003
Primary completion
2004
Study completion
2006
First posted
Jun 4, 2007
Registry last updated
Apr 4, 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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