Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

NCT01405911 | Completed Phase 2 Results

• 2 other identifiers: 0431-105MK-0431-105
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (3)

• Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8

  Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.

  Baseline (Week 0) and Week 8

• Percentage of Participants Who Experienced One or More Adverse Events (AEs)

  An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 10 weeks

• Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)

  An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 8 weeks

Secondary Outcomes (1)

• Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7

  Baseline (Week -1) and Week 7

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

Drug: Placebo for Sitagliptin 25 mg; Drug: Placebo for Sitagliptin 50 mg

Sitagliptin 25 mg

EXPERIMENTAL

Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

Drug: Placebo for Sitagliptin 50 mg; Drug: Sitagliptin 25 mg

Sitagliptin 50 mg

EXPERIMENTAL

Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.

Drug: Placebo for Sitagliptin 25 mg; Drug: Sitagliptin 50 mg

Interventions

Placebo for Sitagliptin 25 mg DRUG

1 tablet orally once daily before breakfast for 8 weeks

Placebo; Sitagliptin 50 mg

Placebo for Sitagliptin 50 mg DRUG

1 tablet orally once daily before breakfast for 8 weeks

Placebo; Sitagliptin 25 mg

Sitagliptin 25 mg DRUG

1 tablet orally once daily before breakfast for 8 weeks

Also known as: MK-0431/ONO-5435

Sitagliptin 25 mg

Sitagliptin 50 mg DRUG

1 tablet orally once daily before breakfast for 8 weeks

Also known as: MK-0431/ONO-5435

Sitagliptin 50 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Impaired glucose tolerance
• On diet/exercise therapy
• Unlikely to conceive
• Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) \<6.1%, Fasting Plasma Glucose \<126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and \<200 mg/dL

You may not qualify if:

• History of diabetes mellitus
• Disease or condition of clear or likely glucose tolerance disorder
• Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.

  PMID: 26094974 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic 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 Director

  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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: August 16, 2011
• Primary Completion: April 9, 2012
• Study Completion: April 9, 2012
• Last Updated: January 18, 2020
• Results First Posted: December 26, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share