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

NCT ID: NCT00704132

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-14
• Study Completion Date: 2010-04-28

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sitagliptin

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

Group Type: EXPERIMENTAL

Comparator: sitagliptin phosphate

Intervention Type: DRUG

Sitagliptin tablet 100 mg, administered once daily before the morning meal.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type: DRUG

Matching placebo tablet, administered once daily before the morning meal.

Interventions

Comparator: sitagliptin phosphate

Sitagliptin tablet 100 mg, administered once daily before the morning meal.

Intervention Type: DRUG

Comparator: placebo (unspecified)

Matching placebo tablet, administered once daily before the morning meal.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.

Reference Type: DERIVED

PMID: 22685234 (View on PubMed)

Other Identifiers

2006_511

Identifier Type: -

Identifier Source: secondary_id

0431-059

Identifier Type: -

Identifier Source: org_study_id