Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Comparator: sitagliptin phosphate; Drug: Comparator: placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704132

0431-059

2006_511

Details and patient eligibility

About

A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

Enrollment: 57 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has type 2 diabetes mellitus
• Males
• Females who are highly unlikely to become pregnant
• Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion criteria

• Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
• Participant required insulin therapy within the prior 8 weeks
• Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

57 participants in 2 patient groups, including a placebo group

sitagliptin

Experimental group

Description:

Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.

Treatment:

Drug: Comparator: sitagliptin phosphate

Placebo

Placebo Comparator group

Description:

Participants randomized to this arm will be administered matching placebo, daily for six weeks.

Treatment:

Drug: Comparator: placebo (unspecified)