Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus (T2DM)

Treatments

Drug: Comparator: placebo to pioglitazone
Drug: Comparator: sitagliptin phosphate
Drug: Comparator: pioglitazone
Drug: Comparator: placebo to sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511108
2007_530
0431-061
MK0431-061

Details and patient eligibility

About

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.

Enrollment

211 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient has type 2 diabetes mellitus
  • Male
  • Female that is highly unlikely to become pregnant
  • Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion criteria

  • Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
  • Patient has required insulin therapy within the past 12 weeks
  • Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the screening visit.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

211 participants in 4 patient groups, including a placebo group

1
Experimental group
Description:
Arm 1: drug
Treatment:
Drug: Comparator: sitagliptin phosphate
Drug: Comparator: placebo to pioglitazone
2
Active Comparator group
Description:
Arm 2: active comparator
Treatment:
Drug: Comparator: placebo to sitagliptin
Drug: Comparator: pioglitazone
3
Experimental group
Description:
Arm 3: drug + active comparator
Treatment:
Drug: Comparator: pioglitazone
Drug: Comparator: sitagliptin phosphate
4
Placebo Comparator group
Description:
Arm 4: placebo comparator
Treatment:
Drug: Comparator: placebo to sitagliptin
Drug: Comparator: placebo to pioglitazone

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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