Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

NCT00541229 | Completed Phase 1 Results

• 2 other identifiers: 0431-0772007_533
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 24-hour Weighted Mean Glucose (WMG)

  The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.

  Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.

Study Arms (3)

1

EXPERIMENTAL

sitagliptin 100 mg

Drug: sitagliptin phosphate

2

EXPERIMENTAL

sitagliptin 200 mg

Drug: sitagliptin phosphate

3

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

sitagliptin phosphate DRUG

sitagliptin 100 mg tablets q.d. (once daily) for 7 days.

Also known as: MK0431

1

Comparator: Placebo DRUG

sitagliptin 100 mg \& 200 mg matching Placebo tablets q.d. (once daily) for 7 days.

3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has Type 2 Diabetes
• Patient is between the ages of 30-65 years
• Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin \[A1C\] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

You may not qualify if:

• Patient has Type 1 Diabetes
• Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
• Patient has taken insulin within the past 3 months

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Alba M, Sheng D, Guan Y, Williams-Herman D, Larson P, Sachs JR, Thornberry N, Herman G, Kaufman KD, Goldstein BJ. Sitagliptin 100 mg daily effect on DPP-4 inhibition and compound-specific glycemic improvement. Curr Med Res Opin. 2009 Oct;25(10):2507-14. doi: 10.1185/03007990903209514.

  PMID: 19691426 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Limitations and Caveats

The pre-specified rule for non-superiority of sitagliptin 200 mg compared with 100 mg was met at the planned interim analysis. As such, the trial was terminated as pre-specified.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 10, 2007
• Study Start: August 24, 2007
• Primary Completion: June 17, 2008
• Study Completion: July 1, 2008
• Last Updated: May 12, 2017
• Results First Posted: July 28, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share