Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

NCT00305604 | Completed Phase 3 Results

• 3 other identifiers: 0431-047MK0431-0472006_003
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24

  Change from baseline at Week 24 is defined as Week 24 minus Week 0.

  Baseline and Week 24

Secondary Outcomes (3)

• Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

  Baseline and Week 24

• Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24

  Baseline and Week 24

• Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week

  Week 1

Study Arms (2)

1

ACTIVE COMPARATOR

sitagliptin

Drug: sitagliptin phosphate

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

sitagliptin phosphate DRUG

Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.

Also known as: MK0431

1

Comparator: Placebo DRUG

sitagliptin matching placebo for up to a 24-wk treatment period.

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
• Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

You may not qualify if:

• Patients with type 1 diabetes
• History of ketoacidosis or requires insulin use
• Alanine aminotransferase / aspartate aminotransferase \> 2.5 X ULN, triglycerides \> 600 mg/dL, creatinine clearance \< 35 mL/min
• Fasting plasma glucose consistently \> 260 mg/dL
• Poorly controlled hypertension

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. doi: 10.1185/03007995.2011.568059. Epub 2011 Mar 23.

  PMID: 21428727 RESULT

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 22, 2006
• Study Start: March 8, 2006
• Primary Completion: March 12, 2008
• Study Completion: March 12, 2008
• Last Updated: May 11, 2017
• Results First Posted: May 1, 2009

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share