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Completed

NCT Number: NCT00722371

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

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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 is highly unlikely to conceive
  • Patient meets one of the 3 categories is naïve to all antihyperglycemic agent (AHA) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening A1c patient is currently not on AHA with a screening A1c >=7.5 % and =<11.0 % patient is currently on either metformin pr sulfonylurea monotherapy with a screening A1c >=7.0 % and =<9.0 %

Exclusion criteria

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has C=peptide value of =<0.8 ng/mL
  • Patient has previously been treated with insulin, thiazolidinedione (TZD) (rosiglitazone or pioglitazone), any Dipeptidyl peptidase-4 (DPP-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
  • Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
  • Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
  • Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
  • Patient has received treatment with an investigational product within 12 weeks prior to Visit 1

Treatment and study plan

sitagliptin phosphate

Drug

Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.

Other names: Januvia, Tesavel, Xelevia, Ristaben

pioglitazone hydrochloride

Drug

Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4.

Other names: Actos

Matching placebo to sitagliptin

Drug

Matching placebo to sitagliptin orally once daily for 54 weeks.

Matching placebo to pioglitazone

Drug

Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.

metformin

Drug

Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (A1C) at Week 24

    Time frame: Baseline and Week 24

    A1C represents the percentage of glycosylated hemoglobin.

  2. Change From Baseline in A1C at Week 54

    Time frame: Baseline and Week 54

    A1C represents the percentage of glycosylated hemoglobin.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline and Week 24

  2. Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24

    Time frame: Baseline and Week 24

    PMG was measured using the Meal Tolerance Test (MTT).

  3. Change From Baseline in FPG at Week 54

    Time frame: Baseline and Week 54

  4. Change From Baseline in 2-Hour PMG at Week 54

    Time frame: Baseline and Week 54

    PMG was measured using the Meal Tolerance Test (MTT).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jul 25, 2008
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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