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

NCT00704132 | Completed Phase 1 Results

• 2 other identifiers: 0431-0592006_511
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6

  Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

  Baseline and Week 6

Study Arms (2)

sitagliptin

EXPERIMENTAL

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

Drug: Comparator: sitagliptin phosphate

Placebo

PLACEBO COMPARATOR

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

Drug: Comparator: placebo (unspecified)

Interventions

Comparator: sitagliptin phosphate DRUG

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

sitagliptin

Comparator: placebo (unspecified) DRUG

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

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22685234 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: February 14, 2007
• Primary Completion: April 28, 2010
• Study Completion: April 28, 2010
• Last Updated: May 12, 2017
• Results First Posted: May 16, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share