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

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ClinicalTrials.gov Identifier: NCT00722371
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : October 17, 2011
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin phosphate Drug: Pioglitazone hydrochloride Drug: Matching placebo to sitagliptin Drug: Matching placebo to pioglitazone Drug: Metformin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1615 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 5, 2008
Primary Completion Date : October 26, 2010
Study Completion Date : March 25, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sitagliptin 100 mg Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Other Names:
  • Januvia
  • Tesavel
  • Xelevia
  • Ristaben
Drug: Matching placebo to pioglitazone
Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks.
Drug: Metformin
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.
Experimental: Pioglitazone 15 mg Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Drug: Metformin
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.
Experimental: Pioglitazone 30 mg Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Drug: Metformin
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.
Experimental: Pioglitazone 45 mg Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Matching placebo to sitagliptin
Matching placebo to sitagliptin orally once daily for 54 weeks.
Drug: Metformin
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.
Experimental: Sitagliptin 100 mg/ Pioglitazone 15 mg Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Other Names:
  • Januvia
  • Tesavel
  • Xelevia
  • Ristaben
Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Metformin
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.
Experimental: Sitagliptin 100 mg/ Pioglitazone 30 mg Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Other Names:
  • Januvia
  • Tesavel
  • Xelevia
  • Ristaben
Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Metformin
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.
Experimental: Sitagliptin 100 mg/ Pioglitazone 45 mg Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks.
Other Names:
  • Januvia
  • Tesavel
  • Xelevia
  • Ristaben
Drug: Pioglitazone hydrochloride
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 Name: Actos
Drug: Metformin
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00722371     History of Changes
Other Study ID Numbers: 0431-102
2008_522 ( Other Identifier: Merck Study Number )
First Posted: July 25, 2008    Key Record Dates
Results First Posted: October 17, 2011
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action